Navigation Links
Cardiva Medical, Inc. Receives FDA Clearance for the Catalyst(TM)III System, First in Class Drug Coated Vessel Closure Device
Date:5/19/2009

MOUNTAIN VIEW, Calif., May 19 /PRNewswire/ -- Cardiva Medical, Inc. announced today 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. For additional information about Cardiva, please visit our website at cardivamedical.com.

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.

    Media Contact:
    Glenn Foy, President
    Cardiva Medical, Inc.
    Phone: 650.475.9855
    Fax: 650.964.8911
    glenn_foy@cardivamedical.com


'/>"/>
SOURCE Cardiva Medical, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Cardiva Medical, Inc. to Present at the UBS 2007 Global Life Science Conference With the Announcement of FDA 510(K) Clearance of its Newest Device: The Boomerang Catalyst II System(TM)
2. Cardiva Medical, Inc. to Present at the UBS 2007 Global Life Science Conference With the Announcement of FDA 510(K) Clearance of its Newest Device: The Boomerang Catalyst II System(TM)
3. Cardiva Medical, Inc. Appoints Two New Officers: Malcolm Farnsworth as Vice President of Finance and Chief Financial Officer and Tara Zerby as Vice President of Business Development and Marketing
4. Cardiva Medical, Inc. to Present Highlights of the Boomerang Catalyst(TM) II System at the Investment in Innovation (In3) West Conference on February 29, 2008 in Las Vegas, NV
5. Cardiva Medical, Inc. Completes $15.5 Million Private Equity Financing
6. Cardiva Medical, Inc. to Present at the Investment In Innovation (In3) Medical Device Summit on June 18, 2008 in San Francisco, CA; Announces the Completion of Its Latest Phase in Its US Sales Force Expansion
7. Cardiva Medical Announces Presentation at BMO Capital Markets 2008 Focus on Healthcare Conference
8. Medical, technological advances prompt updating of nuclear medicine technologists scope of practice
9. Thermage, Inc. Announces Distribution Agreement With Eclipse Medical, Ltd.
10. Medical, Behavioral Woes Can Drive Dogs to Bite
11. ReBuilder Medical Technologies, Inc. Announces UK Demand for Safe Molluscum Contagiosum Treatment Leads to Distribution Agreement with UFFE Medical, LTD. Expected 10% Sales Increase.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... ... 08, 2016 , ... Brenton Engineering , powered by ... flow wrapped products at WestPack 2015, February 9-11, in Anaheim, California. This new ... semi-automatic or fully-automatic case packing with a small footprint, rugged, highly flexible, and ...
(Date:2/8/2016)... ... February 08, 2016 , ... Local ... the greater Venice, FL area, has initiated a fundraiser for a two year ... just four days after Christmas. To support this beautiful child who is facing ...
(Date:2/8/2016)... ... February 08, 2016 , ... FileHold's document management software has ... a cloud hosted environment for FileHold software that is pay per user subscription-based ... applications using the FileHold web services API. DocuSyst also advises clients on fully ...
(Date:2/8/2016)... ... February 08, 2016 , ... ... speaking on how healthcare companies can use newly released government data on populations ... a population and intervene and capture the value they create to succeed in ...
(Date:2/7/2016)... Birmingham, Lake Orion, Clarkston, Metamora, Michigan (PRWEB) , ... February 07, ... ... women on Friday in recognition of National Wear Red Day. National Wear Red ... heart disease and stroke in women. Heart disease and stroke cause 1 in 3 ...
Breaking Medicine News(10 mins):
(Date:2/8/2016)... , Feb. 8, 2016 In a historic vote among ... plans to construct a medical cannabis cultivation facility and dispensary on tribal ... of New York as a provider for patients in the ... York as a provider for patients in the state,s Medical ... 29% (34) to approve the project and pursue designation from the ...
(Date:2/8/2016)... , Feb. 8, 2016 ... the "Knee Reconstruction Devices Market by Product ... Implants), and Geography (U.S., Canada, Eu-5, Japan, Bric, ... 2020" report to their offering. ... of the "Knee Reconstruction Devices Market by ...
(Date:2/8/2016)... , Feb. 8, 2016  The University of ... announced today that, as part of the development ... of the first hospitals in the U.S. to start ... Muraszko , M.D., U-M,s chair of neurosurgery. ... neurosurgery. --> The BrightMatter technology from ...
Breaking Medicine Technology: