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Vacular Example 3:
Deep Vein Thrombosis (DVT) - Thrombolysis

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Table of Contents

(A small sampling of results from a September 1 to October 16, 2006 MIB Abstract Alert search)

Archived Abstracts

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Summary

Bacchus Vascular
Trellis Infusion-8 System & Thrombolysis Catheter & Bacchus
EKOS
Abstract Title Lead Author Publication Pub Date

EKOS to be Honored as Tibbetts Award Winner

None Given Business Wire 9/26/06
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Lysus Peripheral [Ultrasound] System & Micro Infusion Catheter & EKOS
Possis Medical
Abstract Title Lead Author Publication Pub Date

Possis Medical, Inc., to Present at the UBS Global Life Sciences Conference

None Given Business Wire 9/25/06
Possis gets clearance for occlusion system to manage blood flow in peripheral interventions None Given Hematology Week 9/18/06
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AngioJet PowerPulse System & Possis Medical
Abstract Title Lead Author Publication Pub Date

It's been a long recovery for Possis Medical ; The Coon Rapids maker of a clot-busting device struggled after a clinical trial went awry, but executives think they've found a winning strategy.; [METRO Edition]

Janet Moore Star Tribune 9/11/06
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Thrombosis
Abstract Title Lead Author Publication Pub Date

Venous thrombosis and thromboembolism in children with osteomyelitis.

Crary SE J Pediatr 10/4/06
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Femoral Veins & Thrombosis
Iliac Veins & Thrombosis
Abstract Title Lead Author Publication Pub Date

Doppler evaluation of external iliac vein hemodynamic changes caused by lymphocele after lymphadenectomy for cervical cancer.

Bianek-Bodzak A J Clin Ultrasound 10/8/06
Obstructive lesions of the inferior vena cava: clinical features and endovenous treatment. Raju S J Vasc Surg 10/4/06
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Iliofemoral Veins & Thrombosis
Infra-renal Veins & Thrombosis
Abstract Title Lead Author Publication Pub Date
Obstructive lesions of the inferior vena cava: clinical features and endovenous treatment. Raju S J Vasc Surg 10/4/06
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Popliteal Veins & Thrombosis
Tibial Veins & Thrombosis

Full Abstracts

Bacchus Vascular
Trellis Infusion-8 System & Thrombolysis Catheter & Bacchus
EKOS

EKOS to be Honored as Tibbetts Award Winner

Business Wire. New York: Sep 26, 2006.  pg. n/a

EKOS Corporation of Bothell, Washington has been selected as one of the winners of the 2006 Tibbetts Awards. Doug Hansmann will receive the award on Sept. 26 at the Wyndham Washington, located at 1400 M Street NW in Washington, D.C.

Named for Roland Tibbetts--the person acknowledged as the father of the Small Business Innovation Research (SBIR) program--these prestigious, national awards are made annually to those small firms, projects, organizations and individuals judged to exemplify the very best in SBIR achievement. EKOS is one of 55 companies in the U.S. to receive this award. EKOS was select from over 4,000 companies that receive contract and grants under the SBIR Program each year.

EKOS Corporation has developed ultrasound enhanced drug delivery catheters that are small enough to travel through blood vessels and quickly dissolve dangerous clots that can develop in the upper extremity, legs and pelvis.

Coined Ultrasound Accelerated Thrombolysis (USAT), the technology unlocks the clot making it more available to drugs called lytics that liquefy the clot and restore blood flow. Once the clot is removed, the physician can determine the cause of the blood clot and take corrective action.

The EndoWave catheter is commercially available for treatment of blood clots in peripheral arteries, veins and grafts. The NeuroWave catheter has shown early promise in the treatment of stroke causing clots in the brain and is currently part of a National Institute of Health stroke trial.

The complete list of winners can be found at tibbettsawards.org.

Proquest Identifier: 1136143421
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Lysus Peripheral [Ultrasound] System & Micro Infusion Catheter & EKOS
Possis Medical

Possis Medical, Inc., to Present at the UBS Global Life Sciences Conference

Business Wire. New York: Sep 25, 2006.  pg. n/a

Possis Medical, Inc. (NASDAQ:POSS), today announced that it is participating in the UBS Global Life Sciences Conference at The Grand Hyatt Hotel in New York on Wednesday, September 27, 2006. Jules Fisher, vice president of finance and CFO, and John Riles, director of global marketing and new business development, are scheduled to present a company overview and discuss Possis' pioneering medical technologies to conference attendees at 7:30 a.m. ET.

A live Webcast of the presentation will be available at 7:30 a.m. ET on Wednesday, September 27, at www.possis.com under the "Investors" tab. A replay will be available beginning approximately three hours after the live presentation at the same address until October 28, 2006.

Proquest Identifier: 1136147171
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Possis gets clearance for occlusion system to manage blood flow in peripheral interventions

Hematology Week via NewsRx.com & NewsRx.net September 18, 2006

Possis Medical, Inc. (POSS) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its GuardDog Occlusion System for use during the treatment of peripheral vascular disease.

The GuardDog System enables physicians to manage local blood flow while employing interventional techniques and devices to treat vascular disease.

The GuardDog Occlusion System is the first guidewire-based occlusion device designed and marketed with the specific challenges of the peripheral vasculature in mind. It features a 0.035" diameter guidewire, preferred for peripheral interventions, and a soft, compliant, CO2-filled balloon providing quick inflation and deflation.

Designed to facilitate delivery of over-the-wire interventional tools, the GuardDog System can be delivered through 0.038" diagnostic catheters to the treatment site. The GuardDog System can be inflated, deflated and positioned up to three times during a single procedure, improving efficiencies in both routine and complicated procedures. These GuardDog System features enable physicians to manage blood flow and achieve desired occlusion in peripheral vessels 3-6mm in size.

Possis is completing necessary production requirements in preparation for market evaluations at select medical sites to support full U.S. market release of the GuardDOG System by the end of the calendar year. Anticipated revenue from the GuardDOG System is reflected in the company's current guidance for fiscal 2007.

In addition to the 0.0035" GuardDog device, Possis is also developing a 0.014" version of the device. The company expects 510(k) clearance for the 0.014" version later in fiscal 2007.

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AngioJet PowerPulse System & Possis Medical

It's been a long recovery for Possis Medical ; The Coon Rapids maker of a clot-busting device struggled after a clinical trial went awry, but executives think they've found a winning strategy.; [METRO Edition]

Star Tribune. Minneapolis, Minn.: Sep 11, 2006.  pg. 1.D

Janet Moore

In the summer of 2004, Bob Dutcher headed a fast-growing medical technology company. And then one day that August, its stock plunged 40 percent and hasn't fully recovered since.

What happened to spur a $350 million fall in the company's value?

The short answer is that Dutcher's company, Coon Rapids-based Possis Medical Inc., released unexpectedly negative results from a clinical trial involving its signature product, a blood-clot buster called AngioJet that was already on the market.

The 480-patient trial studied whether heart attack patients benefited from treatment by the AngioJet device in addition to receiving an artery-clearing stent for coronary artery disease. The use of AngioJet, and the company's revenue, likely would have increased if the study went well. Instead, it failed to show any benefit from adding AngioJet to the treatment mix.

Suddenly, executives at Possis had to switch from a well-hewn growth strategy to a recovery plan. "It's been a tough two years," Dutcher, the company's chief executive, said in a recent interview. "But we're now ready to return to a growth phase."

The company, which has remained profitable, continues to invest in research and development, hoping to broaden AngioJet's reach, and to develop and market new products as well. Part of the strategy involves a study of 500 patients in Europe that may counter the results of the earlier trial. Company officials say the original study was flawed because its control group - those patients who receive the standard treatment or a placebo - had an unexpectedly low mortality rate.

The AngioJet pumps pressurized saline through arteries and veins to remove blood clots. The clots are sucked into a catheter and pulverized in the process.

Each year, more than 10 million people suffer from circulation- blocking blood clots.

The clots reduce or block blood flow, sometimes leading to a heart attack, stroke, loss of a limb or even death.

The AngioJet is now used to eliminate blood clots largely in coronary and peripheral arteries and bypass grafts, but new uses, including one to treat deep-vein thrombosis (or blood clots in the legs), are pending before the Food and Drug Administration (FDA). The company also is awaiting clearance for its Ultra console, the reconfigured brains of the AngioJet system, which it says is easier for doctors to use.

All told, Possis is awaiting FDA clearance for seven products or new uses for existing products.


Proquest Identifier: 1126188991
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Thrombosis

Venous thrombosis and thromboembolism in children with osteomyelitis.***

J Pediatr. 2006 Oct;149(4):537-41.

Crary SE, Buchanan GR, Drake CE, Journeycake JM.

University of Texas Southwestern Medical Center at Dallas, Divisions of Pediatric Hematology-Oncology and General Pediatrics, Department of Pediatrics, Dallas, Texas.

OBJECTIVE: To determine the prevalence and clinical features of deep vein thrombosis (DVT) complicating osteomyelitis during childhood. STUDY DESIGN: We retrospectively reviewed medical records of all patients with osteomyelitis admitted to Children's Medical Center Dallas between July 1, 2003 and December 31, 2004. Analysis was performed on patients with proximal upper or lower extremity, pelvic or vertebral osteomyelitis (a subgroup considered to be at highest risk for infection-related thrombosis). RESULTS: Thirty-five patients had confirmed osteomyelitis of the proximal humerus, proximal tibia/fibula, femur, pelvis, or vertebrae. Ten of these 35 children (29%) developed DVT during the acute infection based on imaging studies performed. Eight thrombi occurred adjacent to the infection and two occurred in relation to central venous catheters. Six of the 10 children with DVT also had evidence of infection disseminated to lung, brain, or heart, compared with only 1 of 25 patients without DVT (P = .001). Hospitalization was longer in those with DVT than without (33.5 v. 14.2 days, P = .001). CONCLUSION: Thromboembolic complications can occur in the setting of osteomyelitis, and affected patients may be at higher risk of disseminated infection.

PreMedline Identifier: 17011328

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Femoral Veins & Thrombosis
Iliac Veins & Thrombosis

Doppler evaluation of external iliac vein hemodynamic changes caused by lymphocele after lymphadenectomy for cervical cancer. ***

J Clin Ultrasound. 2006 Oct;34(8):393-7.

Bianek-Bodzak A, Sliwinski W, Mielcarek P.

The First Radiology Unit, Medical University of Gdansk, ul. Kliniczna 1 a 80-402, Gdansk, Poland.

PURPOSE: To use Doppler sonography to assess the hemodynamic changes in the external iliac vein (EIV) compressed by a pelvic lymphocele after pelvic lymphadenectomy in patients with cervical cancer. MATERIALS AND METHODS: Postoperative gray-scale and Doppler sonographic examinations were performed in 71 women after pelvic lymphadenectomy. Twenty healthy women served as controls. When present, the lymphocele was graded on a scale of 1 to 4 based on the percentage of the circumference of iliac vessels in contact with the lymphocele (ie, circumferential contiguity) (grade 1, 0-24%; grade 2, 25-49%; grade 3, 50-74%; grade 4, 75-100%), and in 3 groups according to its maximum diameter (group A, 1-40 mm; group B, 41-60 mm; group C, >60 mm). EIV velocity was measured, and waveform modulation by respiratory movements was analyzed. RESULTS: There were 40 lymphoceles in 22 patients. The mean (+/-SD) EIV velocity was 24.5 +/- 14.8 cm/s in the control group, 38.2 +/- 5.9 cm/s in group 1, 69.2 +/- 29.4 cm/s in group 2, 105.75 +/- 12.36 cm/s in group 3, and 139.5 +/- 33.79 cm/s in group 4. Spontaneous EIV blood flow could not be detected in 2 cases in the later group. EIV flow modulation was significantly lower in patients with greater lymphocele contiguity or diameter. CONCLUSIONS: Post-pelvic lymphadenectomy causes EIV extrinsic compression that results in upstream blood stasis, potentially increasing the risk for deep vein thrombosis.

PreMedline Identifier: 16944484

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Obstructive lesions of the inferior vena cava: clinical features and endovenous treatment.***

J Vasc Surg. 2006 Oct;44(4):820-7. Epub 2006 Aug 22.

Raju S, Hollis K, Neglen P.

University of Mississippi Medical Center and River Oaks Hospital, Flowood, MS, USA. rajumd@earthlink.net

OBJECTIVE: Chronic obstructions of the inferior vena cava (IVC) are associated with many odd features. Even total occlusions may remain entirely silent or present late with acute symptoms. Renal dysfunction is rare. Many have chronic symptoms, but often only one limb is affected. We describe the clinical features in a series of 120 patients seen over a 10-year period and the results of successful stent placement in 99 limbs. METHODS: Patients with acute onset of symptoms due to distal thromboses underwent catheter-directed thrombolysis. Patients with significant chronic symptoms were investigated by duplex, venous function tests, transfemoral venography and finally intravascular ultrasound (IVUS). Stenotic segments were balloon dilated and occluded segments were recannalized when feasible; stents were placed under IVUS control. RESULTS: In the asymptomatic group, 10 patients with total occlusions had transient or no occlusive symptoms. In the acute symptom group, four patients with chronic IVC occlusions presented with acute onset of deep venous thrombosis distal to the occlusion but became asymptomatic when the clot was lysed. In the chronic symptom group, 97 patients (99 limbs) had symptoms of chronic venous disease of variable distribution and intensity. In two-thirds, limb symptoms were unilateral. Pathology was total occlusion in 14%, and the rest were stenoses. The lesion extended above the renal vein in 18%. Common iliac obstruction was concurrent in 93%. Distal reflux was present in 66%. Modifications of the basic stent technique were required in recanalization of total occlusions (four extending up to the atrium), two bilateral stent deployments, and nine IVC filter cases. Stent deployment across the renal and hepatic veins or the contralateral iliac vein had no adverse sequelae. Stent patency (cumulative) at 2 years was 82%. Complete relief (cumulative) of pain and swelling at 3.5 years was 74% and 51%, respectively. The cumulative rate of complete ulcer healing at 2 years was 63%. Overall clinical outcome was rated as good or excellent in 70%. CONCLUSIONS: The unusual clinical features of IVC obstructions seem related to the rich collateralization, which has an embryonic basis. Common iliac vein patency seems to be a crucial link in collateral function, and its concurrent occlusion produces symptoms. Percutaneous stent placement has an emerging role in the treatment of IVC obstructive lesions, with good mid-term stent patency and clinical results.

PreMedline Identifier: 16926084

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Iliofemoral Veins & Thrombosis
Infra-renal Veins & Thrombosis

Obstructive lesions of the inferior vena cava: clinical features and endovenous treatment.***

 

>> Click here see article above in Iliac Veins & Thrombosis

 

PreMedline Identifier: 16926084

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Popliteal Veins & Thrombosis
Tibial Veins & Thrombosis
 
 

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