Navigation Links
BridgePoint Medical Announced 510(k) Clearance for an Expanded Indication to Treat Coronary Chronic Total Occlusions
Date:5/16/2011

MINNEAPOLIS, May 16, 2011 /PRNewswire/ -- BridgePoint Medical, Inc., a Minnesota-based medical device company, has announced that they have received clearance of an expanded indication for the CrossBoss™ Catheter and Stingray™ System from the FDA.  The expanded indication includes the intraluminal placement of conventional guidewires beyond stenotic coronary lesions [including chronic total occlusions (CTOs)] prior to PTCA or stent intervention.  CTOs are chronically stenosed lesions that completely block a coronary artery – typically for 3 months or longer - and prevent blood circulation to critical areas of the heart.  

Company Founder & COO Chad Kugler reflected, "This is the culmination of 5 years of development, clinical and regulatory work.  We are grateful for the opportunity to market these products for the specific challenge they were developed for and confident that we have created a great solution for treating CTOs."

This expanded indication is the result of data generated from the 147-patient FAST-CTOs clinical trial in which the safety and effectiveness of the system in coronary chronic total occlusions was demonstrated.

Dr. William Lombardi of St. Joseph's Hospital in Bellingham, WA and a leading enroller in the clinical trial states, "The BridgePoint system is the first set of devices designed specifically for treating coronary Chronic Total Occlusions that has shown real improvements in safety, procedural efficiency, and clinical success rates.  The clinical trial has proven that these arteries can be opened effectively with these products and now with the expanded indication from the FDA there will be a new level of awareness among physicians and patients."

BridgePoint's ability to commercialize its CrossBoss™ Catheter and Stingray™ System will be greatly expanded with this new level of indication.  BridgePoint is the first interventional device company to be granted this specific type of approval for both crossing and re-entry technologies to be used in the treatment of coronary CTOs.

Company CEO and President Denis Harrington says, "We are excited about the expanded indication.  The FAST-CTO Trial demonstrated the safety and effectiveness of the CrossBoss Catheter and Stingray System in treating these most challenging lesions – CTOs.  And we are poised to be the leader in helping physicians treat these patients."

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 Names Industry Veteran as Chief Executive Officer
2. BridgePoint Medical Closes $9.1 Million Series C Financing
3. BridgePoint Medical®, Inc. Completes and Submits to FDA in the U.S. FAST-CTOs With the CrossBoss® and Stingray® CTO Recanalization System
4. BridgePoint Medical(R) Receives European CE Mark for Stingray(R) and CrossBoss(TM) for Opening Completely Blocked Arteries
5. UBM Canon Medical Device Content Team Announces Upcoming Virtual Event Content Topics
6. FDA Formally Accepts Dune Medicals MarginProbe™ System Pre-Market Approval (PMA) Application and Grants Expedited Review Status
7. STMicroelectronics Reveals Best-in-Class Technology Enabling Longer-Lasting Broadcast and Medical-Imaging Equipment
8. Reportlinker Adds Impact of Healthcare Reforms on the Medical Technology Industry
9. Winner Medical to Present at Oppenheimer 5th Annual China Dragon Conference
10. Royce Receives Coveted Medical Products Award
11. Medical Care Technologies Inc. Selects Geographical Location for Flagship Childrens Health Center
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... and SAN CLEMENTE, Calif. , June 24, ... -based mobile pulmonary function testing company, is now able to perform ... developed by ndd Medical Technologies , Inc. ... in hospital-based labs.  Thanks to ndd,s EasyOne PRO ® , ARL ... can get any needed testing done in the comfort of her ...
(Date:6/24/2016)... , June 24, 2016  Arkis BioSciences, ... less invasive and more durable cerebrospinal fluid treatments, ... funding.  The Series-A funding is led by Innova ... Fund, and other private investors.  Arkis, new financing ... instrumentation and the market release of its in-licensed ...
(Date:6/23/2016)... Ill. , June 23, 2016  In a startling report ... are failing their residents by lacking a comprehensive, proven plan to ... a definitive ranking of how states are tackling the worst ... to only four states – Kentucky , ... Vermont . Of the 28 failing states, three ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... ... legally blind and certified personal trainer is helping to develop a weight loss fitness plan ... fix the two major problems leading the fitness industry today:, , ... They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX ... Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over ... Cut Pro X . Simply select a ProHand generator and drag it above media ...
(Date:6/25/2016)... ... 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, whether it’s ... setting the bar too high can result in disappointment, perhaps even self-loathing. However, those ... goal. , Research from PsychTests.com reveals that behind the tendency to ...
(Date:6/24/2016)... Dallas, Texas (PRWEB) , ... June 24, 2016 ... ... 12th International Conference and Scientific Sessions in Dallas that it will receive two ... Announcement of the grants came as PHA marked its 25th anniversary by recognizing ...
(Date:6/24/2016)... , ... June 24, 2016 , ... People across the ... Genome magazine’s Code Talker Award, an essay contest in which patients and their families ... to be presented at the 2016 National Society of Genetic Counselors (NSGC) Annual Education ...
Breaking Medicine News(10 mins):