Navigation Links
TriReme Medical, Inc. Receives FDA 510(K) Clearance for Chocolate PTA Balloon Catheter

PLEASANTON, Calif., Dec. 21, 2011 /PRNewswire/ -- TriReme Medical, Inc. ("TriReme"), a leading developer of innovative devices for the treatment of complex vascular disease, announced today that it has received 510(K) clearance from the U.S. Food and Drug Administration to market its Chocolate PTA balloon catheter ("Chocolate") for the treatment of occluded peripheral arteries. Chocolate was developed in collaboration with TriReme's subsidiary, Quattro Vascular Pte Ltd in Singapore. Chocolate's novel design incorporates a constraining structure over a semi-compliant balloon to facilitate the formation of small modules ("pillows"). Through this advance mechanism of action, Chocolate minimizes shear stress and allows for uniform inflation and rapid deflation. The Chocolate "pillows" can expand locally to facilitate plaque modification and are designed to lower the strain and trauma induced on the vessel wall.

"I am very excited to be the first physician to use Chocolate PTA in the US," said Dr. Jihad Mustapha, Director of Endovascular Interventions and Research at Metro Health Hospital in Wyoming, Michigan. "We treated complex occlusions with outstanding results, no elastic recoil and no dissections which are the most feared complications in patients with Critical Limb Ischemia. This product will be a crucial tool in the battle against Critical Limb Ischemia and major amputations."

"We are pleased to receive US regulatory approval for Chocolate PTA," added Eitan Konstantino, PhD, President and CEO of TriReme. "Chocolate is a great addition to our line of proprietary peripheral PTA catheters already available in the US, Europe and Asia. We are thrilled with Dr. Mustapha's initial US experience and believe that Chocolate will provide substantial clinical benefits to patients suffering from peripheral vascular disease, both above and below the knee."

About TriReme Medical, Inc.

Based in Pleasanton, California, TriReme Medical, Inc. is a privately held medical device company dedicated to the development, manufacturing, and commercialization of next generation percutaneous devices for the treatment of complex coronary and peripheral arterial disease. The Company's novel interventional therapies are specifically designed for large, unmet clinical needs.


SOURCE TriReme Medical, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. TriReme Medical Inc. Receives CE Marking for Antares(TM) Coronary Stent System
2. TriReme Medical, Inc. Receives FDA 510K Clearance for Glider(TM) PTA Balloon Catheter
3. TriReme Medical Announces $17 Million Series D Financing
4. TriReme Medical Announces Japanese Alliance
5. TriReme Medical Lines Up Asian Strategy With Key Appointment of New Board Members
6. Prescient Medical, Inc. Acquires New Technology to Detect Inflammation in Coronary Blood Vessels
7. Prescient Medical, Inc. Achieves Successful Clinical Debut of vProtect(TM) Luminal Shield
8. China Sky One Medical, Inc. Announces 26 New Drugs in Clinical Trials
9. China Sky One Medical, Inc. Achieves Significant Breakthrough in Research for Sudden Cardiac Death (SCD) Early Examination Kit
10. New Study Shows that Prebiotics, as Used by Jackson GI Medical, Increases Lifespan by 33%
11. Luminous Medical, Inc. Secures Exclusive Rights to Glucose Sensor for Its Automated Glucose Monitor
Post Your Comments:
(Date:6/23/2016)...  MedSource announced today that it has selected ... of choice.  This latest decision demonstrates MedSource,s commitment ... clients by offering a state-of-the-art electronic data capture ... as the EDC platform of choice in exchange ... has long been a preferred EDC platform by ...
(Date:6/23/2016)... a startling report released today, National Safety Council research ... proven plan to eliminate prescription opioid overdoses. Prescription Nation ... tackling the worst drug crisis in recorded U.S. history, assigned a ... , New Mexico , Tennessee ... failing states, three – Michigan , ...
(Date:6/23/2016)... , June 23, 2016 Research and ... News Issue 52" report to their offering. ... influenza treatment creates a favourable commercial environment for MedImmune to ... patient base that will serve to drive considerable growth for ... would serve to cap sales considerably, but development is still ...
Breaking Medicine Technology:
(Date:6/25/2016)... Oklahoma City, Oklahoma (PRWEB) , ... June 25, ... ... to helping both athletes and non-athletes recover from injury. Recently, he has implemented ... for the Oklahoma City area —Johnson is one of the first doctors to ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of ... of the latter, setting the bar too high can result in disappointment, perhaps even ... progress toward their goal. , Research from reveals that behind ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events ... turn to unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. ... tools for healthy coping following a traumatic event. , Trauma sufferers tend to feel ...
(Date:6/24/2016)... ... ... was in a crisis. Her son James, eight, was out of control. Prone to extreme ... “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there was ... other children and say he was going to kill them. If we were driving ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, ... Elite. The attorneys chosen by their peers for this recognition are considered among the ... Traurig Shareholders received special honors as members of this year’s Legal Elite Hall of ...
Breaking Medicine News(10 mins):