Cardiva Medical, Inc. Receives FDA Clearance For The Catalyst TM III System, Early In Class Narcotic Coated Vessel Closure Slogan
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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 succeeding to the device. Resident heparin reversal by the Catalyst III system facilitates quick and efficient vessel closure as an adjunct to notebook compression in patients undergoing anticoagulation with heparin. Catalyst III's protamine coating contacts the tissue tract from the arteriotomy site to the end of percutaneous entry in the skin. Cardiva estimates that annually 1.7 million patients in the United States admit 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 advantage of the Catalyst III system took dwelling in the Cardiovascular Faculty of the South located at Terrebonne Accepted 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 affirm that localized protamine in the tissue tract makes a considerable difference. Not only can we accomplish rapid, essential vessel closure for our patients, however we can also improve our efficiency while utilizing a more cost-effective and time-tested anticoagulant."
"As the Company formally announces the marketplace start of this new product today, the Catalyst III further demonstrates Cardiva's intelligence to evolve its technology platform to proper the sui generis 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 big economic valuation to the health disquiet process by facilitating throughput in patients who are anticoagulated with heparin, and permitting clinicians to significantly lower the overall payment of anticoagulation."
About Cardiva Medical, Inc.
Cardiva Medical, Inc., a privately held medical device gathering that designs, develops and commercializes endovascular products which advice the target heal itself. In 2005, Cardiva launched its cardinal 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 cause 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 actually 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
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