Cardiva Medical, Inc. Receives FDA Clearance For The Catalyst(TM)III System, First In Class Drug Coated Vessel Closure Device

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 20 May 2009 - 1:00 PDT

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Cardiva Medical, Inc. announced that it has received clearance from the U.S. Food & Drug Administration (FDA) for its latest technology, the Cardiva Catalyst III, which is considered the first drug coated vessel closure device in the market.

Built upon its predecessor, the Catalyst III is coated with protamine sulfate, a drug which neutralizes heparin in the tissue adjacent to the device. Local heparin reversal by the Catalyst III system facilitates quick and efficient vessel closure as an adjunct to manual compression in patients undergoing anticoagulation with heparin. Catalyst III's 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 United States 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."

"As the Company formally announces the market launch of this new product today, the Catalyst III further demonstrates Cardiva's ability to evolve its technology platform to meet the unique needs of patients in the vessel closure market," commented Augustine Lien, Founder, Chairman, and CEO of Cardiva Medical, Inc. "We expect the Catalyst III to deliver strong economic value to the health care system by facilitating throughput in patients who are anticoagulated with heparin, and permitting clinicians to significantly lower the overall cost of anticoagulation."

About Cardiva Medical, Inc.

Cardiva Medical, Inc., a privately held medical device company that designs, develops and commercializes endovascular products which help the body heal itself. In 2005, Cardiva launched its first product into the vessel closure market, the Boomerang(R) Wire System, which demonstrated unsurpassed ease-of-use and safety. The Catalyst III device is indicated for use in heparinized patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F, or 7F introducer sheaths. In January 2008, Cardiva launched its latest vessel closure system, the Cardiva Catalyst(TM) II, which incorporates hemostatic agents to accelerate the body's own coagulation pathway; quickly facilitating hemostasis at the arteriotomy site, preserving the artery and leaving absolutely nothing behind in the patient. In 2006, Cardiva was presented the prestigious Frost & Sullivan Award which recognizes entrepreneurial excellence in the U.S. angioplasty and vascular closure devices market.

Cardiva Catalyst, Boomerang and Boomerang Catalyst are trademarks/registered trademarks of Cardiva Medical, Inc.

This product is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.

Source: Cardiva Medical, Inc