Navigation Links
BridgePoint Medical Announces US IDE Approval and First Patient Enrollment of Peripheral Chronic Total Occlusion Study
Date:8/3/2011

MINNEAPOLIS, Aug. 3, 2011 /PRNewswire/ -- BridgePoint Medical, Inc., a Minnesota-based medical device company, has announced that they have enrolled their first patient in the Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions (PFAST-CTOs) study.  The company received approval from the FDA in July, 2011 to move forward with the US based IDE for the peripheral devices and is now actively enrolling patients.  The 10 center, 100 patient U.S. PFAST-CTOs study is designed to assess the safety and effectiveness of the BridgePoint devices in chronically occluded arteries located in the lower extremities.

Dr. Subhash Banerjee of the VA North Texas Health Care System and UT Southwestern Medical Center, the first physician to enroll a patient in the PFAST-CTOs study, stated, "Predicated by the success of the BridgePoint coronary CTO system, we are very optimistic about the Peripheral device's performance possibilities and we are looking forward to a robust and successful study."

The BridgePoint peripheral products are similar to the coronary system in concept, but have been specifically designed and adapted for use in peripheral vasculature and will expand the company's reach into the fast growing peripheral market.  

Company CEO and President Denis Harrington reflected, "This is a very important milestone for BridgePoint Medical. With the IDE approval and the first case enrolled, we are now officially started in our quest to build a strong Peripheral CTO franchise to complement our market leading Coronary CTO franchise."      

About Peripheral Artery Disease and Chronic Total Occlusions:

Atherosclerotic peripheral artery disease (PAD) is a widely prevalent disorder that affects millions world-wide and is associated with significant morbidity and mortality.  A CTO, which represents a complete artery blockage, typically cannot be treated with standard endovascular interventional devices and is often treated with surgery or medical therapy.  Patients with lower extremity CTOs often suffer from poor circulation in the legs often resulting in debilitating leg pain (claudication), limb threatening ischemia, and limb amputation.  Various studies have estimated that Chronic Total Occlusions (CTOs) are common and are found in approximately 50% of patients who undergo angiography.

About BridgePoint Medical:

BridgePoint Medical, Inc. is a privately held company established in 2006 to design, develop and commercialize new technologies and techniques to treat challenging coronary and peripheral artery disease.   Investors include New Enterprise Associates, Polaris Venture Partners, Foundation Medical Partners and Michael Berman. 


'/>"/>
SOURCE BridgePoint Medical, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. BridgePoint Medical(R) Receives European CE Mark for Stingray(R) and CrossBoss(TM) for Opening Completely Blocked Arteries
2. BridgePoint Medical®, Inc. Completes and Submits to FDA in the U.S. FAST-CTOs With the CrossBoss® and Stingray® CTO Recanalization System
3. BridgePoint Medical Closes $9.1 Million Series C Financing
4. BridgePoint Medical Names Industry Veteran as Chief Executive Officer
5. BridgePoint Medical Announced 510(k) Clearance for an Expanded Indication to Treat Coronary Chronic Total Occlusions
6. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
7. You May Have a Thyroid Problem and Not Know It - Particularly If Youre Over 60, Says a New Harvard Medical School Report
8. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
9. Globus Medical Raises $110 Million in Series E Financing Round
10. Quark Pharmaceuticals Appoints New Chief Medical Officer
11. Boston University Biomedical Engineers Find Chink in Bacterias Armor
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)... , May 24, 2016  Joe Marziani has joined VMS BioMarketing as senior vice ... officer, today. In his new role, Marziani will lead the company,s business development and ... to improve outcomes. Photo - http://photos.prnewswire.com/prnh/20160523/371089 ... ... ...
(Date:5/24/2016)... May 24, 2016 ... , la première endoprothèse à double ... à l,intervention portant sur les membres inférieurs ... OrbusNeich, entreprise mondiale spécialisée dans la ... la vie, a élargi son portefeuille pour ...
(Date:5/24/2016)... May 24, 2016 Een app ... zodat zij collectief patiënten kunnen behandelen, hun kennis kunnen ... idee achter de nieuwe en revolutionaire MDLinking App, ontwikkeld ... Nederlandse vaatchirurg dr. Hans Flu en oncologisch chirurg dr. ... inmiddels beschikbaar is, wordt op dinsdag 24 mei officieel ...
Breaking Medicine Technology:
(Date:5/26/2016)... , ... May 26, 2016 , ... W.S. Badger ... has been honored with a 2016 When Work Works Award for its use of ... of the national When Work Works project administered by the Families and Work Institute ...
(Date:5/26/2016)... , ... May 26, 2016 , ... On Memorial Day, ... women who lost their lives in military battle for the country. The nonprofit ... 2015 to provide more programs that empower independence for disabled military veterans, as well ...
(Date:5/26/2016)... ... May 26, 2016 , ... ... solutions for drugs, biologics, consumer health and global clinical supply services, today announced ... to support the company’s continued investment and strategic growth plans in the Asia ...
(Date:5/26/2016)... ... May 26, 2016 , ... Leadership of ... today announced the organization has earned its ISO 13485 certification, indicating the company’s ... with all rules and policies associated with ISO quality standard 13485. , ...
(Date:5/26/2016)... ... May 26, 2016 , ... ... and chief medical officer of Blue Horizon International (BHI), Brian Mehling, M.D., spoke ... was held during May 5-6, 2016 in Chicago, IL, USA. Dr. Mehling’s presentation ...
Breaking Medicine News(10 mins):