MOUNTAIN VIEW, Calif., Dec. 26 /PRNewswire/ -- Cardiva Medical, Inc., a privately held medical device company, announced today it has been selected by Frost & Sullivan as the recipient of the 2006 Frost & Sullivan Award for Entrepreneurial Company in the U.S. angioplasty and vascular closure devices market. Cardiva is an emerging company focusing on developing and commercializing next-generation vascular access management and closure devices with unsurpassed safety and ease-of-use when compared to existing closure options.
Each year Frost & Sullivan presents this Award to the small company that demonstrated superior entrepreneurial ability in its industry during the research period. This Award signifies the company's identification of a unique and revolutionary product solution with significant market potential. Additionally, it certifies the company's marketing strategy as sound and poised for success.
"Cardiva has earned this Award for its development of the Boomerang(TM) Wire System, a radical arteriotomy site-specific compression technology that enables effective management of the access site," says Frost & Sullivan Research Analyst Archana Swathy. "The device aids physicians to seal the femoral artery puncture site after percutaneous interventional or diagnostic procedures have been performed." Archana continued "More than 40,000 patients have been treated with this device and the results have been promising, with no device related major complications. The proven clinical safety of the device offers Cardiva a solid base from where it can further expand into the market."
"The Boomerang Wire System is a new novel vascular access management approach which combines the natural elastic recoil of the artery with a small wire which replaces the sheath and temporarily dwells in the artery at the end of the vascular procedure. By temporarily plugging the arterial pressurized arteriotomy hole, the arterial vessel does what it naturally wants to do ... 'close,'" says Dr. Ron G. Smalling, MD, a leading Interventional Cardiologist who practices at St. John's Mercy Regional Health Center in Springfield, Missouri. Dr. Smalling has placed more than 400 Boomerang devices in patients and has seen the tremendous benefits of the Boomerang System as many of his colleagues do around the country. "This mechanism allows for natural relaxation of the arteriotomy and also promotes natural healing of the artery and tissue tract without leaving anything behind to scar or infect the artery. The Boomerang Wire System can be deployed in less than a minute in both diagnostic and interventional procedures in the vascular catheterization lab. This quick deployment of the boomerang wire combined with a brief manual compression yields a great benefit for the vascular patient in achieving final hemostasis." Dr. Smalling believes the Boomerang system technology represents a significant and important advance in the vascular access management for the ever expanding endovascular approaches to cardiovascular patients.
After the temporary hemostasis is achieved and the device is left indwelling to allow for the re-coiling of the artery to occur, the device is removed from the artery. The bleeding from the needle puncture in the artery is stopped by slight compression. "Unlike many other devices, called vascular closure devices, which are frequently used to close the arteriotomy site after the procedure, the Boomerang does not leave debris in the tissue or artery, which eliminates an important risk of infection," observes Archana. "Furthermore, the simplicity, safety, and ease of use of the device allows the ancillary staff in the catheterization lab to handle the device on the patient."
Augustine Y. Lien, founder, Chairman and Chief Executive Officer of Cardiva, said, "We believe that the Boomerang Wire System is not only far more comfortable and cost-effective for patients undergoing percutaneous procedures, but is also a significant advancement in patients safety and ease- of-use for medical practitioners. We are pleased to have been selected for the prestigious 2006 Frost & Sullivan Award for Entrepreneurial Company in the U.S. angioplasty and vascular closure devices market. It is gratifying and encouraging that the analysts at Frost and Sullivan are recognizing the clinical and cost benefits of the Boomerang technology, and confirming our marketing strategy as sound and poised for success."
About the Boomerang Wire System
The Boomerang Wire System is designed to be more comfortable and cost- effective for patients undergoing percutaneous procedures, and also provide extreme safety and ease-of-use when compared to existing vascular closure devices or traditional manual compression used to close the femoral artery following catheterization.
It is estimated that almost twelve million percutaneous catheterizations are performed world-wide annually. At the end of the percutaneous procedure, the thin Boomerang device is inserted into the artery through the existing arterial sheath used during the catheterization procedure. Once inside the artery, the Boomerang device opens a flat, low-profile disc. Upon removal of arterial sheath, the Boomerang disc is positioned against the opening of the femoral artery forming a tight seal and immediate hemostasis.
Once the patient arrives into the recovery room, the Boomerang disc is collapsed and completely removed from the artery, leaving nothing behind in the tissue tract or artery. Final closure occurs with just a few minutes of finger pressure on the arterial puncture site. The safety and ease of use of the Boomerang device is in sharp contrast to the traditional methods doctors have used to close the opening of the femoral artery, which include manual compression directly over the femoral puncture site or vascular closure devices which use various biomaterials (e.g., collagen, sutures, staples, or gels) to create a physical seal of the opening in the femoral artery.
The Boomerang Wire System has been cleared by the U.S. Food and Drug Administration to assist clinicians in managing and closing femoral artery puncture sites, following percutaneous procedures including angiography, angioplasty or stenting. The Boomerang Wire System has also obtained the CE, which allows commercialization in the European Union countries. The global vascular closure market opportunity is estimated to be $1.5 billion to $2.0 billion
About Cardiva Medical, Inc.
Founded in July, 2002, and headquartered in Mountain View, Calif., Cardiva Medical, Inc. is a privately held medical company focused on developing and commercializing vascular access site management and closure devices with unsurpassed safety and ease-of-use. Following FDA clearance of the Boomerang Wire System, the Company began actively marketing the device through its direct sales organization in the United States in the second half of 2005. Cardiva Medical, Inc. is funded by leading venture capital investors, including Galen partners, Stockton Partners, Sycamore Ventures, Harbinger Venture Corp., and W.I. Harper Group. Additional information about Cardiva Medical, Inc. can be found on www.cardivamedical.com.
NOTE: Cardiva, Boomerang are trademarks/registered trademarks of Cardiva Medical, Inc.
Media Contacts: Glenn Foy, President Cardiva Medical, Inc. Phone: 650.964.8900, x 215 Fax: 650.964.8911 glenn_foy@cardivamedical.com
Cardiva Medical, Inc.CONTACT: Glenn Foy, President of Cardiva Medical, Inc., +1-650-964-8900,ext. 215, or fax, +1-650-964-8911, or glenn_foy@cardivamedical.com
Web site: http://www.cardivamedical.com/
