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- DES Stent
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Abbott Receives CE Mark for Smaller-Size XIENCE(TM) V Drug Eluting Stent; New 2.25 mm Diameter Stent Now Available in Europe, Asia and Latin America
Lead Author: [none given]
PR Newswire. New York:, 2008-03-11
ABBOTT PARK, Ill., March 11 /PRNewswire-FirstCall/ -- Abbott** (NYSE: ABT) announced today that it has received CE Mark (Conformite Europeene) approval for a 2.25 mm version of its XIENCE(TM) V Everolimus Eluting Coronary Stent System**, offering physicians a smaller stent based upon the proven efficacy, positive safety results and excellent deliverability of XIENCE V. The addition of the 2.25 mm stent to the XIENCE V portfolio gives physicians access to a wider range of stent sizes for treating a variety of patient types.
The 2.25 mm version of the XIENCE V stent will be launched immediately in the majority of European markets and select countries in Asia and Latin America. In addition to the 2.25 mm stent, XIENCE V is available in stent diameters of 2.5 mm, 2.75 mm, 3.0 mm, 3.5 mm and 4.0 mm for lesions 28 mm or shorter.
Coronary artery disease (CAD) occurs when arteries become narrow due to plaque buildup, restricting blood flow to the heart. Approximately 30 to 40 percent of CAD lesions occur in vessels equal to or less than 2.5 mm in diameter.
XIENCE V is the only drug eluting stent to demonstrate superiority over another drug eluting stent in a randomized clinical trial. In the SPIRIT family of trials, XIENCE V demonstrated:
-- Superiority for XIENCE V compared to TAXUS(R)** paclitaxel eluting
coronary stent system in the primary endpoint of angiographic In-Stent
Late Loss in the SPIRIT II clinical trial at six months, with a
statistically significant 69 percent reduction for XIENCE V. In-stent
late loss is a measure of vessel renarrowing within the margins of the
stent.
-- Superiority for XIENCE V compared to the TAXUS in the primary endpoint
of angiographic In-Segment Late Loss at eight months in the SPIRIT III
clinical trial, with a statistically significant 50 percent reduction
for XIENCE V. In-segment late loss is a measure of vessel renarrowing.
-- An observed 43 percent reduction in major adverse cardiac events (MACE)
compared to TAXUS at one year in SPIRIT III**. MACE is an important
clinical measure of safety and efficacy outcomes for patients, and is
defined as cardiac death, heart attack (myocardial infarction or MI),
or ischemia-driven target lesion revascularization (TLR associated with
symptoms or documented lack of blood supply).
-- Non-inferiority to TAXUS with an observed 23 percent reduction in
Target Vessel Failure (TVF) for XIENCE V compared to TAXUS in the
SPIRIT III clinical trial at one year. Target Vessel Failure is a
measure of re-treatment anywhere within the target vessel and includes
cardiac death or heart attack.
Additionally, data from an independent pooled subset analysis of SPIRIT II and SPIRIT III at one year showed:
-- A statistically significant 59 percent reduction in angiographic
In-Stent Late Loss for XIENCE V compared to TAXUS for lesions in a
reference vessel diameter less than 2.5 mm.
-- An observed 61 percent reduction in angiographic In-Segment Late Loss
for XIENCE V compared to TAXUS for lesions in a reference vessel
diameter less than 2.5 mm.
XIENCE V was launched in Europe and other international markets in late 2006.
XIENCE V is an investigational device in the United States and Japan, and is currently under review for approval by the U.S. Food and Drug Administration.
Abbott also supplies a private-label version of XIENCE V to Boston Scientific called the PROMUS(TM) Everolimus-Eluting Coronary Stent System. PROMUS is designed, studied and manufactured by Abbott and supplied as part of a distribution agreement between the two companies.
MIB Abstract ID Number: 14832
Proquest Identifier: 1443360021
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Wyeth, J&J Sue Medtronic Over Stent Patents
Lead Author: [none given]
Devices & Diagnostics Letter, 2008-03-11, Vol. 35 No. 10
Less than a month after the FDA approved Medtronic's** Endeavor drug-eluting stent, both Wyeth** and Johnson & Johnson (J&J) filed suit over the product.
The companies filed a patent infringement suit in the U.S. District Court for the District of New Jersey last month alleging the zotarolimus-eluting stent infringes on the claims of three patents owned by Wyeth and licensed to J&J -- the '781, '146 and '728 patents.
These patents relate to the use of rapamycin, or sirolimus, and its analogues -- including zotarolimus. The '781 patent describes a method of treating restenosis in humans undergoing a percutaneous transluminal angioplasty procedure with an effective amount of rapamycin. The '146 and '728 patents both describe a method of preventing or treating hyperproliferative vascular disease by administering rapamycin.
This lawsuit may not threaten Medtronic's stent profits immediately. RBC Capital Markets analysts predicted the case "will probably take many years to work its way through the federal court system."
The plaintiffs have asked the court to enjoin Medtronic from selling the stent in the U.S. While injunction requests are standard in such cases, they are rarely granted, RBC said.
"In the coronary stent market, everybody seems to be suing everybody else, and by our count, there are over two dozen pending patent litigations across various jurisdictions related to drug-eluting stents," the analysts said.
J&J, for instance, has been "vigorously defending its turf" in the U.S. drug-coated stent market, initiating seven infringement suits over the past 10 months on "olimus" claims, RBC added.
Of these, four were filed against Abbott**, accusing the Xience V stent** of infringement, and two were filed against Boston Scientific's** Promus.
The FDA approved the Endeavor stent Feb. 1, and U.S. sales began that day (D&DL, Feb. 11). -- April Astor
MIB Abstract ID Number: 14874
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Oregon Bioscience Association Names New Board Officers and Directors
Lead Author: [none given]
Pharma Business Week, 2008-03-10, EXPANDED REPORTING; Pg. 2479
Bill Newman returns as chairman of the Oregon Bioscience Association (OBA) Board of Directors for 2008. Newman is managing director with Northwest Technology Ventures. Other OBA board officers for 2008 are Carla Rathbun, secretary, consultant; Raymond Cheung, treasurer, Geffen Mesher & Co.; and Carol Pratt, legal counsel, K & L Gates.
Along with the officers, serving on the OBA Board of Directors for 2008 will be Doug Linquest, Welch Allyn; John Morgan, HemCon Medical Technologies; John Tortorici, Chart Solutions; Lew Nashner, Neurocom International, Inc.; Mary Erichsen, IBM Life Sciences; Phil Benz, Advanced Vascular Dynamics; Ann Bunnenberg, Electrical Geodesics, Inc.; Ann Demaree, Compview Medical; and Barry Starkman, Genentech. Also serving on the board are Blaine Metting, Pacific Northwest National Laboratory; Corey Schmid, Respironics; David Lyon, Bend Research, Inc.; Dianne Danowski Smith, The Ulum Group; Gordon Brown, Invitrogen; Greg Hahn, Synthetech Inc.; Jake Langer, Biotronik USA; Mark Haldeman, Evergreen Engineering; Nathan Gibson, Skanska USA; Jeff King, Virogenomics; Bob Monaghan, Oregon Translational Research and Drug Development Institute; Rich Linton, University of Oregon; Roger Weyel, AMES Technology; Sandy Shotwell, Alta Biomedical; Tim Stout, M.D., Oregon Health & Science University; Todd Hill, Precision Wire Components; and Ron Sherman, Silicon Valley Bank.
Alternates include Peter Murray, Welch Allyn; Arun Pradhan, Oregon Health & Science University; John Bial, Invitrogen; Juergen Lindner, Biotronik USA**; Keith Martin, Precision Wire Components; Tina Kellogg, Bend Research Inc.; and Todd Kaufman, Genentech.
MIB Abstract ID Number: 14865
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Boston Scientific to Participate in Lehman Brothers Health Care Conference
Lead Author: [none given]
PR Newswire, 2008-03-11
NATICK, Mass., March 11 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) is scheduled to participate in the Lehman Brothers Health Care Conference, which is being held March 18 - 20 in Miami, Florida.
Paul LaViolette, Chief Operating Officer, will make a 25-minute presentation on Tuesday, March 18, beginning at approximately 9:00 a.m. E.T. Sam Leno, Executive Vice President and Chief Financial Officer will join Mr. LaViolette in a question and answer session.
A live webcast of Mr. LaViolette's remarks and the question and answer session will be available to all interested parties at Boston Scientific's website at http://www.bostonscientific.com. To ensure a timely connection to the webcast it is recommended that users register at least 15 minutes before the webcast begins.
This webcast is being hosted by Lehman Brothers. The replay will be archived and available in the Investor Relations site at http://www.bostonscientific.com.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific.com.
CONTACT: Paul Donovan
508-650-8541 (office)
508-667-5165 (mobile)
Media Relations
Boston Scientific Corporation
Larry Neumann
508-650-8696 (office)
Investor Relations
Boston Scientific Corporation
MIB Abstract ID Number: 14872
Proquest Identifier: 1443746421
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Research and Markets Adds Report: 'Analysis of Boston Scientific'
Lead Author: [none given]
Wireless News, 2008-03-11
WIRELESS NEWS-March 11, 2008-Research and Markets Adds Report: 'Analysis of Boston Scientific' (C)2008 10Meters - http://www.10meters.com
Research and Markets has announced the addition of "Analysis of Boston Scientific**" to its offerings.
In a release, Research and Markets noted that report highlights include:
We present Analysis of Boston Scientific. A complete and comprehensive analysis of Boston Scientific, includes an overview of the industry the company operates in, a PEST Framework Analysis of the industry, and then moves on to analyzing the company itself.
Company analysis includes a history of Boston Scientific, a business segment analysis of the segments Boston Scientific operates through, a look at the organization structure of the company, a geographical operating segments analysis, an analysis of the company s major competitors.
A financial analysis of Boston Scientific is presented in the report which includes a ratio analysis, basic profit and loss analysis, presentation of the company balance sheet, and much more.
A SWOT Framework Analysis of Boston Scientific completes this in-depth company analysis.
Companies mentioned:
- St. Jude Medical Inc.**
- Medtronic Inc.**
Report information:
www.researchandmarkets.com/reports/c85079
MIB Abstract ID Number: 14876
Proquest Identifier: 1443913261
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U.S. Patents Awarded to Inventors in Massachusetts
Lead Author: [none given]
Targeted News Service. , 2008-03-07
ALEXANDRIA, Va., March 7 -- The following federal patents were awarded to inventors in Massachusetts.***Massachusetts Inventors Develop Stapling Unit for Endolumenal Stapling SystemALEXANDRIA, Va., March 7 -- Gary McAlister of Natick, Mass., and Robert L. Sakal of Bolton, Mass., have developed a stapling unit for an endolumenal stapling method.According to the U.S. Patent & Trademark Office: "A stapling unit for use with an endoscopic stapling system adapted to be advanced along an endoscope to a predetermined location within a body lumen to staple the portion of tissue, as part of an occlusal or full thickness resectioning procedure. The stapling unit comprises a first casing having a distal end, a proximal end and a stapling device mounted thereto adjacent to a first window extending through a periphery of the first casing. The invention includes methods for the stapling, severing and removal of tissue by using the device."The inventors were issued U.S. Patent No. 7,334,718 on Feb. 26.The patent has been assigned to Boston Scientific** Scimed Inc., Maple Grove, Minn. The original application was filed on Jan. 26, 2004, and is available here.
***Massachusetts Inventor Develops Direct Digital Synthesis CircuitALEXANDRIA, Va., March 7 -- Jaso Messiern of Boston has developed a direct digital synthesis (DDS) circuit with arbitrary frequency control clock.According to the U.S. Patent & Trademark Office, the invention relates to a "test system using direct digital synthesis for generation of a spectrally pure, agile clock. The clock is used in analog and digital instruments in automatic test system. A DDS circuit is synchronized to the tester system clock because it is clocked by a DDS clock generated from the system clock. Accumulated phase error is reduced through the use of a parallel accumulator that tracks accumulated phase relative to the system clock. At coincidence points, the accumulated phase in the DDS accumulator is reset to the value in the system accumulator."The inventor was issued U.S. Patent No. 7,336,748 on Feb. 26.The patent has been assigned to Teradyne Inc., North Reading, Mass.The original application was filed on Dec. 23, 2003, and is available here.***Massachusetts Inventors Develop Free List, Ring Data Structure Management MethodALEXANDRIA, Va., March 7 -- Gilbert Wolrich of Framingham, Mass., Mark B. Rosenbluth of Uxbridge, Mass., Debra Bernstein of Sudbury, Mass., John Sweeney of Harvard, Mass., and James D. Guilford of Northborough, Mass., have developed a free list and ring data structure management method. According to the U.S. Patent & Trademark Office, the invention relates to a "method of managing a free list and ring data structure, which may be used to store journaling information, by storing and modifying information describing a structure of the free list or ring data structure in a cache memory that may also be used to store information describing a structure of a queue of buffers."The inventors were issued U.S. Patent No. 7,337,275 on Feb. 26.The patent has been assigned to Intel Corp., Santa Clara, Calif. The original application was filed on Aug. 13, 2002, and is available here.***Massachusetts Inventors Develop Digital Data Processing SystemALEXANDRIA, Va., March 7 -- Simon Korowitz and Harold Lake, both of Sharon, Mass., and Harris D. Kagan of Foxboro, Mass., have developed a digital data processing system.An abstract of the invention, released by the U.S. Patent & Trademark Office, said: "A field controller for use in a distributed control system including an area controller and at least one field controller. The field controller manages at least one controlled device in an industrial process operation. The field controller comprises a processor module segment through which it can control a selected number of devices, and it may also include one or more expansion module segments to enable it to control a larger number of controlled devices. The processor module segment includes a processor module and at least one local interface module for interfacing to a controlled device, and the expansion module segment includes interface modules for interfacing to other controlled devices. In the processor module segment, the processor module and said local interface module are interconnected by a bus segment, which is also connected to an upstream off-module connector. Each expansion module segment includes at least one interface module, and also includes a downstream off-module connector and an upstream off-module connector, which are interconnected by a bus segment. The downstream off-module connector of each expansion module segment is adapted to mate with the upstream off-module connector of the processor module segment and of other expansion module segment, so as to facilitate the interconnection of the processor module segment and a sequence of expansion module segments by establishing a unitary multi-drop bus comprising the processor module's bus segment and the bus segments of expansion module in the sequence. The processor module controls each controlled device through the respective local interface module or expansion interface module connected thereto. The processor module segment and each expansion module segment are each mounted in a housing segment which is configured to form a unitary housing when they are interconnected."The inventors were issued U.S. Patent No. 7,337,256 on Feb. 26.The patent has been assigned to Invensys Systems Inc., Foxboro.The original application was filed on Nov. 25, 2003, and is available here.***Massachusetts Inventors Develop Low Latency Data Transmission MethodALEXANDRIA, Va., March 7 -- Almir Davis of Quincy, Mass., Jeffrey S. Kinne of Needham, Mass., Christopher S. MacLellan of Walpole, Mass., and Stephen L. Scaringella of Holliston, Mass., have developed a low latency data transmission method.According to a description of the invention, released by the U.S. Patent & Trademark Office: "The present invention is directed generally to a data transmission system and, more particularly, to a data transmission system having improved latency with a reduced gate count and minimal number of handshake signals."The inventors were issued U.S. Patent No. 7,337,250 on Feb. 26.The patent has been assigned to EMC Corp., Hopkinton, Mass.The original application was filed on Dec. 30, 2004, and is available here.***Massachusetts Inventors Develop Magnetic ChainsALEXANDRIA, Va., March 7 -- Harpreet Singh of Cambridge, Mass., and T. Alan Hatton of Sudbury, Mass., have developed a rigid magnetic chain.An abstract of the invention, released by the U.S. Patent & Trademark Office, said: "One aspect of the present invention relates to a permanently linked, rigid, magnetic chain of particles prepared by sol-gel methods. A second aspect of the present invention relates to a method of preparing a permanently linked, rigid, magnetic chain of particles comprising: coating a core material with one or more polyelectrolyte layers resulting in a coated particle; further coating the coated particle with a layer of magnetic nanoparticles resulting in a magnetic particle; coating the magnetic particle with a layer of a polycationic polyelectrolyte resulting in a coated magnetic particle; and applying a magnetic field to the coated magnetic particle in the presence of a metal oxide or metal oxide precursor capable of undergoing hydrolysis."The inventors were issued U.S. Patent No. 7,332,101 on Feb. 19.The patent has been assigned to Massachusetts Institute of Technology, Cambridge, Mass. The original application was filed on June 25, 2004, and is available here.***Massachusetts Inventors Develop Wireless Application Code Identification ApparatusALEXANDRIA, Va., March 7 -- Deepak Mathew of North Billerica, Mass., Aiguo Yan of North Andover, Mass., Zoran Zvonar of Boston, and Abhay Sharma of Wakefield, Mass., have developed an apparatus for code identification in wireless application.According to the U.S. Patent & Trademark Office: "A system and method are provided for determining whether a chipping code from a group of codes is used in a signal. In one embodiment of the invention, a signal is received and each code from the group is correlated with the received signal. The ratio of the highest correlation value to the second highest correlation value is calculated."An abstract of the invention, released by the Patent Office, said: "If the ratio exceeds a threshold, the chipping code may be determined as the chipping code used in the signal. In another embodiment, the ratio of the highest correlation value and the total received power of the signal is calculated. If the ratio exceeds a threshold, the chipping code may be determined as the chipping code used in the signal."The inventors were issued U.S. Patent No. 7,336,699 on Feb. 26.The patent has been assigned to Analog Devices Inc., Norwood, Mass.The original application was filed on Feb. 19, 2003, and is available here.
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MIB Abstract ID Number: 14879
Proquest Identifier: 1441981501
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U.S. Patents Awarded to Inventors in Florida
Lead Author: [none given]
Targeted News Service., 2008-03-07
Florida Inventors Develop Guidewire Processing, Packaging MethodALEXANDRIA, Va., March 7 -- Boris Kesler of Pembroke Pines, Fla., Yudit Candocia of Bradenton, Fla., and Otto E. Anderhub of Miami, have developed a method of processing and packaging a guidewire.According to the U.S. Patent & Trademark Office, the invention relates to a "device comprising an elongated tubular member having a first open end, a second open end and a lumen therebetween, the first end and the second end facing in the same direction and positioned so that a first end of a guidewire can extend beyond the device out of the first open end and a second end of the guidewire can extend beyond the device out of the second open end and parallel to the first end of the guidewire and a method of manufacturing and packaging a guidewire comprising the steps ofproviding a dual distal tip guidewire having a first tip and a second tip, providing a coiled elongated tubular device having a first open end positioned proximate and facing in the same direction as a second open end, and positioning the guidewire in the tubular device."The inventors were issued U.S. Patent No. 7,334,678 on Feb. 26.The patent has been assigned to Boston Scientific** Scimed Inc., Maple Grove, Minn.The original application was filed on Feb. 13, 2004, and is available here.
MIB Abstract ID Number: 14880
Proquest Identifier: 1441981441
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Boston Scientific Names Schnitzer to Clinical Sciences Organization
Lead Author: [none given]
Wireless News, 2008-03-07
WIRELESS NEWS-March 7, 2008-Boston Scientific Names Schnitzer to Clinical Sciences Organization (C)2008 10Meters - http://www.10meters.com
Boston Scientific** announced that Jay J. Schnitzer, M.D., Ph.D. will be joining the Company's Clinical Sciences organization effective March 24.
Dr. Schnitzer will serve as Vice President and Associate Chief Medical Officer, sitting on the Clinical Leadership team and reporting to the Chief Medical and Scientific Officer, Dr. Donald S. Baim, M.D. In his new role, Dr. Schnitzer will be responsible for leading the medical input process for the Company's Endosurgery, Neurovascular and Neuromodulation businesses. He will also participate in the formulation and execution of technology strategies for both internal research and development, as well as external business development activities. In addition, he will oversee development and dissemination of scientifically based education materials relating these areas.
Dr. Schnitzer most recently has served as Associate Professor of Surgery at Harvard Medical School, Visiting Surgeon at Massachusetts General Hospital (MGH) and Pediatric Surgeon at Shriners Burns Hospital in Boston. He trained in medicine at Harvard Medical School and earned a Ph.D. in chemical engineering from the Massachusetts Institute of Technology. Dr. Schnitzer's major research interests are related to developmental biology of the lung and congenital diaphragmatic hernia (CDH), and combat casualty care.
Dr. Schnitzer is a member of several national and international societies, including the American Surgical Association, the Association for Academic Surgery, the American Pediatric Surgical Association, the American Burn Association and the British Association of Pediatric Surgeons.
Dr. Schnitzer is also the surgical team leader of the National Disaster Medical System International Medical Surgical Response Team and was deployed to New York City on September 11, 2001 and Bam, Iran following a 2003 earthquake. In addition, Dr. Schnitzer represented the MGH in the Center for the Integration of Medicine and Innovative Technology, an inter-institutional consortium that seeks new technology solutions for unmet needs in various medical disciplines, where he worked alongside Dr. Baim who represented the Brigham and Women's Hospital until joining Boston Scientific in 2006.
"We are delighted to have Dr. Schnitzer joining our team," said Dr. Baim. "He is a senior clinician who brings a unique background to bear on our Clinical Sciences organization, and he will provide invaluable medical leadership for these critical business areas."
Boston Scientific is a developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.
MIB Abstract ID Number: 14881
Proquest Identifier: 1442163511
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Eye disease cure: Electric therapy?
Lead Author: Thomas Lee.
McClatchy - Tribune News Service, 2008-03-06
MINNEAPOLIS -- Electricity has been used to shock hearts, ease pain and even treat depression. Now, apparently, it can even thwart blindness.
ScyFix, a Chanhassen, Minn., start-up, has developed a device that treats diseases such as glaucoma and macular degeneration by shooting electric currents into the eye. The company, which is conducting clinical trials in India and the United States, hopes to sell the first device approved by the Food and Drug Administration designed to restore eyesight.
"To me, this is the pacemaker for the eye," said Dr. Darrell DeMello, ScyFix president and a former executive at Boston Scientific Corp**.
ScyFix, a featured new technology presenter at December's annual Life Science Alley conference, hopes to eventually raise $60 million to $70 million to finish its clinical trials.
Neuromodulation, or electric stimulation, first gained prominence in the 1960s through the use of deep-brain and spinal-cord stimulation to treat pain. Doctors at the time had begun to realize pain was not just the result of the direct activation of pain receptors but rather a complex series of electric and chemical interactions throughout the nervous system. Therefore, electricity could be used to manipulate those interactions.
Medtronic Inc. laid the groundwork for the medical device boom in Minnesota by developing the implantable pacemaker, a device that uses electric impulses to regulate heartbeats. Today, companies like St. Jude Medical and Uroplasty are developing implantable devices to fight chronic pain and incontinence. Doctors are also harnessing electricity to treat Parkinson's disease, deep depression, and obsessive compulsive disorder.
But until now, the idea to use electricity to slow or even reverse the effects of eye diseases like glaucoma has never made it out of a laboratory, said Dr. Thomas Samuelson, a founding partner of Minnesota Eye Consultants. Samuelson, an ophthalmologist, recently developed a new surgical procedure to treat glaucoma in a minimally invasive way.
Neuromodulation for the eyes is "nowhere near the clinical level," said Samuelson, who is not connected to ScyFix. "As a glaucoma specialist, it has never come up as a treatment for glaucoma."
Glaucoma, wet and dry eye macular degeneration, and retinitis pigmentosa, which severely reduce vision or cause blindness, have become more prevalent in the United States, especially as the country's baby boom population ages. People suffering from such age-related diseases will jump from nearly 30 million today to 43 million by 2020, according to the American Academy of Ophthalmologists.
Thomas Harold first came up with the idea for ScyFix in 2002. An Internet entrepreneur and a former executive at General Mills, Harold became interested in studies that showed electricity could restore sight. Drugs, however, could only slow the effects of some diseases.
"I thought to myself: 'No cure? No therapies? That's interesting,'" said Harold, who is now chief executive of ScyFix.
Specifically, the studies showed electricity could stimulate the production of neurotrophins, a family of proteins that can instruct optic nerve, retinal neurons and photoreceptor cells not to die. In addition, neuromodulation can also repair cell membranes, allowing cells to absorb nutrients, release wastes, improve blood flow to the eye and rewire faulty nerve connections.
Working with doctors and engineers, Harold, who has no medical background, developed a device that releases low-intensity electric currents into the eyelids through electrodes. A complex mathematical equation programmed into the device controls the amount and frequency of the electricity. Patients can administer the treatment at home twice a day for 20 minutes.
Harold says he is highly encouraged by the results so far: Since 2002, the device has halted progression of diseases in 95 percent of the 1,000 patients tested in 29 countries, according to ScyFix.
"Everything stopped getting worse," Harold said. "That was a win in itself."
In addition, 80 percent of the patients reported vision improvement. There were no side effects, the company said.
Harold and DeMello envision developing an implantable eye device and possibly using electricity to correct common eye problems such as nearsightedness. But even Harold admits there are many unknowns regarding eye diseases and the effects of electric stimulation.
Still, Samuelson of Minnesota Eye Consultants thinks the treatments are worth exploring.
"If you can stimulate (the nerves) somehow, it might help," he said. "It seems like a reasonable thing to evaluate."(c) 2008, Star Tribune (Minneapolis)Visit the Star Tribune Web edition on the World Wide Web at http://www.startribune.com
Distributed by McClatchy-Tribune Information Services.
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MIB Abstract ID Number: 14882
Proquest Identifier: 1337003591
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Outlook for stents improving
Lead Author: George E Jordan
Newhouse News Service., 2008-03-06
Widespread controversy and confusion about heart stents, the tiny mesh tubes that hold open heart arteries after blockages have been cleared, has been enough to make stent makers and many doctors and patients ill.
Which type of stent, bare metal or drug-coated, is safer? When is it smarter to forgo stents in favor of powerful cholesterol medicine? When, if ever, will the meltdown in stent sales stop?
The chaos appears to be coming to an end as a consensus emerges that drug-coated stents are, indeed, safe. Stent makers hope that new studies and next-generation stents coming on the market this year can revive sales, which sank to $2 billion last year from a peak of $3.1 billion in 2005.
Two months ago, the Food and Drug Administration approved Medtronic's** Endeavor**, the first new entry in the drug-coated stent business since 2004. A decision is expected later this year on Abbott Laboratories'** Xience**, another drug-eluting device Wall Street analysts expect to become the top-selling stent in the U.S. market.
The newcomers arrive as Johnson & Johnson, which previously split the U.S. stent market with Boston Scientific, was forced to abandon development of a new stent last year. The CoStar drug-coated stent** failed in late-stage clinical trials after J&J paid $1.4 billion to acquire the stent's creator, Conor Medsystems**.
Meanwhile, J&J's arch-competitor, Boston Scientific**, will market Abbott's Xience under a profit-sharing deal.
Stent sales, which fell sharply last year after studies raised questions about their safety and effectiveness, could rebound, cardiologists said, because they are beginning to settle on a new rule of thumb for treatment: Drug-coated stents are as safe and effective as bare metal so long as patients take aspirin and a blood thinner such as Plavix **long after the stents are implanted.
Still, Marc Cohen, chief of cardiology at Newark Beth Israel Hospital in New Jersey, said doctors now are less likely to consider stents as the only treatment option for patients with heart disease. He said the number, size and location of artery blockages, along with the patient's overall health, are among many variables doctors now consider when recommending stents, heart medicine or bypass surgery.
"The pendulum first swung willy-nilly about using drug-eluting stents," Cohen said. "Now, there have been longer-term studies that show it is safe to use drug-eluting stents, but you have to be more careful with the Plavix and aspirin. As long as you keep them on drug therapy longer (than one year after the implant), they are safe."
Cohen said the new generation of stents coming on the market "are a little better," but not dramatically so. He said it was "way too early" to make conclusions about their long-term effectiveness and safety.
When stents hit the market in 1994, they solved a problem associated with traditional angioplasty, a procedure in which doctors thread a catheter from the groin into arteries clogged with plaque and deploy a balloon to clear them. Stents prevented the vessels from shrinking and becoming clogged again.
But stents caused another, potentially life-threatening problem of scar tissue forming around the metal mesh tubes and reclogging the artery.
The solution stents coated with drugs that reduce the risk of scar tissue first came on the market in 2003. But the drugs on the mesh have been associated with deadly blood clots months, or even years, after their implantation.
A series of conflicting, high-profile scientific studies over the past two years raised vexing questions about the safety of drug-eluting versus bare-metal stents. The studies had cardiologists picking sides in the dispute and dramatically scaled back the use of stents.
No company was hurt more by the stent controversy than Boston Scientific, which is laying off 2,300 employees, or 13 percent of its work force, in the face of declining sales of its Taxus stent.
Boston Scientific now thinks the tables are about to turn.
It plans to seek approval later this year of Taxus Liberte, the updated version of its top-selling Taxus stent. And once Abbott's Xience wins FDA approval, Boston Scientific will sell its version under the name Promus.
"Our view is we have the best of both worlds," Jeffrey Mirviss, Boston Scientific's vice president of coronary stent marketing, said of the prospect of simultaneously marketing Taxus Liberte and Promus. "We've got Coke and Pepsi and we like that combination. There is no one else that can offer that kind of line-up."
Johnson & Johnson's stent division, Cordis, said its Cypher medicated stent matches up well against the competition and has a long track record.
"No other drug-eluting stent has the monumental amount of data now associated with the Cypher stent," Cordis spokesman Christopher Allman said. "It will take some time before new entrants into the market have this amount of data."
MIB Abstract ID Number: 14883
Proquest Identifier: 1441855421
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Cook Pharmica Names Fred Larimore, Ph.D., Vice President of Scientific Affairs, CSO
Lead Author: [none given]
Lab Law Weekly, 2008-03-07, EXPANDED REPORTING; Pg. 368
Fred Larimore, Ph.D. has been named vice president of scientific affairs and chief scientific officer for Cook Pharmica, the global contract biopharmaceutical manufacturing division of Cook Medical**.
Larimore has more than 25 years of biotech experience beginning at Eli Lilly with the development and manufacturing of recombinant human insulin. His career at Eli Lilly included integral work for recombinant human growth hormone, recombinant human parathyroid hormone, bovine somatotropin, and several research monoclonal antibodies and antibody conjugates. Additionally, he led multiple initiatives in process aspects of facility design, scale-up and start-up.
As one of the top scientists at Eli Lilly**, he was responsible for the redevelopment of the recombinant human insulin and recombinant human growth hormone processes and provided technical leadership and oversight for the company's protein product portfolio prior to joining Cook Pharmica in 2006.
"Fred has provided critical leadership for the development group for the last two years and has been extremely effective in building a strong team," said Cook Pharmica president Jerry Arthur. "His extensive industry experience, scientific expertise, and strong leadership qualities have been foundational to the success of our company and will continue to be as we expand."
MIB Abstract ID Number: 14884
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InnerPulse, Inc. Appoints Elsa Chi Abruzzo as Vice-President of Regulatory and Quality Affairs
Lead Author: [none given]
PR Newswire, 2008-03-06
RESEARCH TRIANGLE PARK, N.C., March 6 /PRNewswire/ -- InnerPulse, Inc., a privately held company with a disruptive technology for the treatment of abnormal heart rhythms, announced the appointment of Elsa Abruzzo to the newly formed position of Vice-President of Regulatory and Quality Affairs. Ms. Abruzzo has more than 18 years of experience in the medical device industry including cardiac devices, such as heart valves, neurovascular embolic devices, and biomaterials.
Ms. Abruzzo, 40, most recently served as Vice-President Regulatory and Clinical Affairs with AtriCure, Inc., a manufacturer of cardiac ablation devices. Prior to that Elsa was with Percutaneous Valve Technologies, Inc. (PVT) where she served as head of regulatory and clinical affairs for a breakthrough percutaneous aortic valve technology. Prior to PVT, Elsa spent 10 years with CryoLife, Inc.** (biomaterials, tissue heart valves and vascular grafts) and Cordis Johnson and Johnson** (vascular devices), all in regulatory and quality affairs.
"We are delighted to have someone with Elsa's extensive experience join our executive team at this important juncture of the Company's evolution. She will have a key leadership role as we initiate our clinical studies and move closer to gaining regulatory approval of our novel defibrillator technology. Her experience in leading several technologies successfully through the regulatory approval process over the past 18 years will provide great value as the Company begins our clinical trials," said InnerPulse President and Chief Executive Officer Daniel A. Pelak.
Elsa is a graduate of the University of Miami with a degree in Industrial and Manufacturing Engineering.
MIB Abstract ID Number: 14886
Proquest Identifier: 1440922211
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Semper Fidelis -- Consumer Protection for Patients with Implanted Medical Devices
Lead Author: William H Maisel
The New England Journal of Medicine, 2008-03-06, Vol. 358, Iss. 10; pg. 985
When the Food and Drug Administration (FDA) approved the Medtronic Sprint Fidelis implantable cardioverter-defibrillator (ICD) lead in 2004 on the basis of bench testing but no human clinical data, there was no public outcry. Physicians rapidly incorporated the new electrode into their practice, welcoming its small diameter and ease of implantation. During the ensuing 3 years, 90% of Medtronic** ICDs were implanted with this lead. But in October 2007, after 38 months on the U.S. market and 268,000 implantations worldwide, the Fidelis was voluntarily recalled by Medtronic because of its propensity to fracture. The large number of affected patients, the billions of dollars at stake in the ICD market, and the controversy surrounding the timing of communication with physicians and patients about the lead's performance highlight the shortcomings of the regulatory system for medical devices and underscore the urgent need for legislation that will ensure adequate protection for the patients receiving them.
MIB Abstract ID Number: 14887
Proquest Identifier: 1441098621
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Recent advances in hemodynamics : noncoronary applications of a pressure sensor angioplasty guidewire.
Lead Author: Cavendish JJ
Additional Authors: Carter LI, Tsimikas S.
Catheter Cardiovasc Interv. , 2008-03-06, [Epub ahead of print]
Department of Cardiology, Naval Medical Center San Diego, San Diego, California.
The use of the pressure sensor coronary guidewire is expanding into the peripheral circulation as well as into the realm of valvular heart disease. Small mechanistic studies and case reports have described the use of pressure wire technology in the renal and femoral arteries as well as in mechanical aortic valves. The use of this technology to measure hemodynamically significant stenoses in noncoronary locations will be discussed and a review of basic and more advanced hemodynamics in relation to problems encountered in clinical practice will be provided. (c) 2008 Wiley-Liss, Inc.
MIB Abstract ID Number: 14830
PreMedline Identifier: 18324696
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Research and Markets: According to New Report , the Global Market for Drug Eluting Stents is Getting Back on Track
Lead Author: [none given]
M2 Presswire, 2008-03-10
M2 PRESSWIRE-March 10, 2008-Research and Markets: According to New Report , the Global Market for Drug Eluting Stents is Getting Back on Track (C)1994-2008 M2 COMMUNICATIONS LTD
After a difficult year seeing global revenue for drug eluting stents declining to US3.9 billion globally from a peak of US$5.1 billion in 2005, the market for drug-coated stents is getting back on track.
Over publicized negative outcome results from a sub-group of clinical studies triggered a reduction in total percutaneous coronary intervention procedures as well as a decrease in penetration levels of drug eluting stents share of these procedures.
New studies emerging from European Society of Cardiology (ESC) and the Transcatheter Cardiovascular Therapeutics (TCT) conferences have re-asserted the underlying safety and efficacy of DES, and challenged earlier negative late stent thrombosis results.
As the dust settles, early positive trends in drug coated stents global sales are emerging and impressive new product launches are expected in the US market in 2008. Waning COURAGE** impact combined with favorable media response to newer longer-term trial results are leading to better device prescription volumes in all geographical segments.
It provides a timely analysis of this market with profiles of leading participants and forecasts to the year 2015.
With Drug Eluting Stents - Technology & Market Forecast, you'll be able to:
1. Understand current market dynamics, competitors positions and market shares.
2. Assess market size and growth potential for these combined drug devices.
3. Monitor the competition's marketed and in-development products.
4. Identify emerging technologies and the companies behind them.
5. Assess market potential and have access to forecasts till 2015.
6. Leverage your own technology and brain storm new business opportunities.
7. Investigate mergers, acquisitions and licensing possibilities
Drug Eluting Stents - Technology & Market Forecast is targeted at busy senior executives in medical technology companies who are interested in developing an understanding of this highly dynamic evolving market.
For more information visit http://www.researchandmarkets.com/reports/c85456
CONTACT: Laura Wood, Senior Manager, Research and Markets
Fax: +353 1 4100 980
e-mail: press@researchandmarkets.com
((M2 Communications Ltd disclaims all liability for information provided within M2 PressWIRE. Data supplied by named party/parties. Further information on M2 PressWIRE can be obtained at http://www.presswire.net on the world wide web. Inquiries to info@m2.com)).
MIB Abstract ID Number: 14833
Proquest Identifier: 1443495781
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Pluristem Therapeutics to Present its Clinical Trial Plans at the Roth Capital Partners 20th Annual OC Growth Stock Conference
Lead Author: [none given]
Lab Business Week, 2008-03-09, EXPANDED REPORTING; Pg. 204
Pluristem Therapeutics Inc. (NASDAQ:PSTI) (DAX:PJT), a leading bio-therapeutics Company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for a variety of malignant, ischemic and autoimmune disorders, announced that it will present its clinical trial plans at the Roth Capital Partners 20th Annual OC Growth Stock Conference in Dana Point, California, USA. The presentation will take place on February 19th at 1 pm Pacific Time and will be web-cast live (at http://wsw.com/webcast/roth16/psti/) and for 90 days following the presentation.
Mr. Zami Aberman, Pluristem's Chairman and CEO commented, "We are very glad to have the opportunity to present our cutting edge cell therapy technology and our clinical programs at the Roth Capital Partners 20th Annual OC Growth Stock Conference. We strongly believe that our PLX cells can revolutionize the treatment of hematological malignancies and peripheral artery disease (PAD) and be therapeutically beneficial to millions of people. The Company is moving forward with its clinical programs and expects to announce its progress with the FDA and the EMEA (the Federal Drug Administration and the European Medicines Agency). Our target is to start our clinical trials in humans during 2008."
MIB Abstract ID Number: 14890
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BioMarin to Present at the Cowen and Company 28th Annual Healthcare Conference
Lead Author: [none given]
PR Newswire, 2008-03-11
NOVATO, Calif., March 11 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc.** (Nasdaq and SWX: BMRN) announced today that Jeff Cooper, Chief Financial Officer of BioMarin, will present a company update at the Cowen and Company 28th Annual Healthcare Conference in Boston on Tuesday, March 18, 2008 at 10:15 a.m. ET.
Interested parties may access a live audio webcast of the presentation via the investor section of the BioMarin website, http://www.BMRN.com. A replay of the presentation will be archived on the site for at least one week following the presentation.
MIB Abstract ID Number: 14891
Proquest Identifier: 1443639251
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Sangamo BioSciences to Present at the Cowen and Company 28th Annual Health Care Conference
Lead Author: [none given]
PR Newswire, 2008-03-11
RICHMOND, Calif., March 11 /PRNewswire-FirstCall/ -- Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced today that Edward Lanphier, Sangamo's president and CEO, will provide an update on the progress of Sangamo's ZFP Therapeutic development programs and an overview of the company's business strategy at 9:30 a.m. (ET) on Tuesday, March 18, 2008 at the Cowen and Company 28th Annual Health Care Conference in Boston.
The presentation will be webcast live and may be accessed via a link on the Sangamo BioSciences website in the Investor Relations section http://investor.sangamo.com/index.cfm under Events and Presentations. The presentation will be archived on the Sangamo website for two weeks after the event.
MIB Abstract ID Number: 14892
Proquest Identifier: 1443778681
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