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Evolutionary Percutaneous Access Management Device Is Safe, Easy to Use and Improves Manual Compression Efficiency
MOUNTAIN VIEW, Calif., Dec. 26 /PRNewswire/ -- Cardiva Medical, Inc., a privately held medical device company, announced that it has been awarded a national multi-source agreement by Premier, Inc, an alliance of not-for-profit hospitals and healthcare systems. This long term agreement provides Premier members with the opportunity to purchase Cardiva's Boomerang(TM) Percutaneous Access Management System ("Boomerang(TM)") on preferred terms and to receive priority training and support services.
Millions of percutaneous catheterizations are performed world-wide each year, with approximately 80% of such procedures being diagnostic angiography. During percutaneous catheterization procedures, the catheter is threaded through the femoral artery to the site of vascular disease (most common is in the heart), where diagnosis and/or treatment (such as stenting or angioplasty), can be performed. Traditionally, doctors have used various methods to close the femoral artery puncture site, including direct manual or mechanical compression over the femoral puncture site or one of the various implantable vascular closure devices, which use various biomaterials (such as collagen, gels, sutures, or staples) to create a physical seal of the femoral artery puncture site.
Direct manual compression can be quite painful for the patient and may require several hours of bed-rest to achieve complete hemostasis; while implantable vascular closure devices achieve hemostasis in minutes, but have been associated with catastrophic complications. Cardiva's Boomerang(TM) is designed to improve manual compression efficiency and to leave nothing behind in the femoral artery or at the puncture site, thereby avoiding the implantable closure device related complications.
In late 2004, Cardiva's Boomerang(TM) received market clearance from the U.S. Food and Drug Administration ("FDA") More than 8,000 patients have been treated with the Boomerang(TM) device following percutaneous procedures in the past 10 months. Clinical results from this large pool of post-market patients have demonstrated the excellent efficacy and safety, with no major complications, of using the Boomerang(TM) device. In practice, at the end of the percutaneous procedure, the Boomerang(TM) device is inserted into the artery through the existing arterial sheath used during the catheterization procedure. Upon removal of arterial sheath, the Boomerang(TM) disc is positioned against the opening of the femoral artery for a tight seal and immediate hemostasis in the cath lab. Once the patient arrives into the recovery room, the Boomerang(TM) disc is collapsed and the device is completely removed from the artery, leaving nothing behind in the tissue tract or artery following the Boomerang(TM) procedure, with final hemostasis achieved with a few minutes of manual compression.
Augustine Y. Lien, founder, Chairman and Chief Executive Officer of Cardiva said, "We believe that the Boomerang(TM) device is not only far more comfortable and cost-effective for patients undergoing manual compression of the femoral artery opening, but also provides unsurpassed safety for patients and ease-of-use for medical practitioners when compared to existing implantable vascular closure devices. We are pleased and encouraged by the fact that Premier is recognizing the clinical and cost benefits of the Boomerang(TM) technology."
More information about Cardiva Medical Inc. and the Boomerang(TM) Percutaneous Access Management System can be found in the company's website at www.cardivamedical.com or by contacting Glenn Foy, President of Cardiva, by email at Glenn_Foy@cardivamedical.com.
About Premier, Inc.
Premier, Inc., the leader in helping hospitals accelerate performance on both clinical outcomes and supply chain costs, is a healthcare alliance entirely owned by more than 200 of the nation's leading not-for-profit hospital and healthcare systems. These organizations operate or are affiliated with nearly 1,500 hospitals and thousands of other healthcare sites. Premier Purchasing Partners provides an array of services supporting health services delivery including group purchasing totaling more than $25 billion annually in supplies and equipment purchasing, as well as supply chain and clinical performance improvement services. Premier Healthcare Informatics offers performance measurement, benchmarking, and reporting products and advisory services supporting quality improvement. Insurance Management Services helps hospitals manage insurance costs and improve risk management and claims capabilities. Headquartered in San Diego, Premier has offices in Charlotte, N.C., Chicago, and Washington. For more information, visit www.premierinc.com.
About Cardiva Medical, Inc.
Cardiva Medical, Inc. ("The Company") was found as a California corporation in July 2002. The company is committed to optimizing the management and closure of percutaneous vascular access site through implementation of advanced technology which improves ease of use, patient safety, and reduces cost. Cardiva's first product, the Boomerang(TM) Percutaneous Access Management System, has obtained the CE Mark in EU countries and received 510(k) market clearance from the FDA in October 2004. The Company has begun its commercialization of Boomerang (TM) in the U.S. since December 2004. With compelling patient safety and demonstrated economic benefits, the new Boomerang(TM) ClosureWire has received very positive response from the cardiac centers and has gained rapid acceptance by the physicians. Headquartered in Mountain View, California, Cardiva has established 25 sales territories across the US, employing a direct sales force. For more information, visit www.cardivamedical.com.
Contact:
Glenn Foy, President, Cardiva Medical, Inc.
925-989-3544
Glenn_Foy@cardivamedical.com
Source: Cardiva Medical, Inc.
Web site: http://www.premierinc.com/
Web site: http://www.cardivamedical.com/
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