Received FDA clearance
for its Cardiva
Catalyst III device
First Drug-Coated Vessel Closure Device Gets FDA Nod
May 20, 2009
Cardiva Medica (Mountain View, CA), has received FDA clearance for its Cardiva Catalyst III device, the first drug-coated vessel closure device on the market, the company says.
The Catalyst III is coated with protamine sulfate, a drug which neutralizes heparin in the tissue adjacent to the device. Local heparin reversal allows for quick and efficient vessel closure when used with manual compression in patients undergoing anticoagulation with heparin, the company says.
The protamine coating contacts the tissue tract from the arteriotomy site to the point of percutaneous entry in the skin. Cardiva estimates that annually 1.7 million patients in the US receive heparin during an endovascular procedure; the majority of these cases are for peripheral vascular disease, the fastest growing segment in the percutaneous procedure market.
Initial use of the Catalyst III system took place in the Cardiovascular Institute of the South located at Terrebonne General Medical Center in Houma, LA, under the direction of its founder, interventional cardiologist, Craig Walker, M.D.
Dr. Walker said of the Catalyst III, "We believe that localized protamine in the tissue tract makes a big difference. Not only can we accomplish rapid, natural vessel closure for our patients, but we can also improve our efficiency while utilizing a more cost-effective and time-tested anticoagulant."
Source: PR Newswire