Healthcare Industry News:  vascular access 

Devices Interventional

 News Release - August 1, 2007

Cardiva Medical, Inc. Launches Boomerang Catalyst System (TM)

Go Beyond Closure with Confidence: Technology Already Proven Successful in 70,000+ Procedures Even Further Enhanced

MOUNTAIN VIEW, Calif., Aug. 1 (HSMN NewsFeed) -- Cardiva Medical, Inc., a privately held medical device company, announced today the recent launch of its new Boomerang Catalyst System (TM) for vascular closure applications. This product builds on the success of its predecessor, the Boomerang Wire System (TM), which has been used to effectively and safely close femoral artery puncture sites in more than 70,000 percutaneous catheterization procedures since 2005. The Catalyst System is the first vascular closure device to achieve final hemostasis in the catheterization lab for diagnostic patients without leaving any foreign materials behind in the vessel, thereby eliminating a major cause of device failure and complication.

Approved for both diagnostic and interventional procedures, Cardiva first introduced the original Boomerang Wire System in May 2005. While continuing to evolve its portfolio to meet the needs of its customers, Cardiva successfully enhanced the Boomerang Wire System in early 2007 by adding a proprietary hemostatic material to the spring-loaded section of the Boomerang Wire which accelerates coagulation adjacent to the puncture site. Cardiva launched this newly approved device in July under the trade name "Boomerang Catalyst System."

During percutaneous catheterizations procedures, a 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 two primary methods to close the femoral artery puncture site: direct manual compression over the puncture site or one of the various implantable vascular closure devices, which use materials (such as collagen, sutures, or staples) to create a physical seal of the puncture site.

There are considerable drawbacks to current approaches. Specifically, manual management of the puncture site requires significant hospital resources, may require several hours of bed-rest, and may result in bleeding-related complications as well as vessel scarring; while vascular closure devices achieve hemostasis in minutes, they have been associated with catastrophic complications and are not suitable for certain patients. Importantly, the Boomerang technology addresses all of these shortcomings.

In a recent presentation at the EuroPCR meeting in Barcelona, Spain on May 22, it was concluded that the Boomerang Catalyst System not only achieved final hemostasis in the cath lab for diagnostic patients, but also allowed interventional patients to get out of bed and walk hours sooner than manual compression patients. Leaving nothing in the tissue tract or artery, the Boomerang Catalyst System has an unprecedented safety profile, eliminating the primary source of implant-related complications which plague current vascular closure devices. Additionally, immediate and future re-access to the vessel is preserved with the Catalyst System as scarring is mitigated compared to existing approaches. The Boomerang Catalyst System also eliminates virtually all tissue tract blood oozing, which is a very common problem when implantable closure devices are used.

Along with the recent introduction of the Boomerang Catalyst System, Cardiva also launched its Pathway Program, a comprehensive clinical education, training and outcomes monitoring program to help clinicians go beyond the discrete event of closure and deliver maximum near and long term benefit to patients, nurses, and physicians in and out of the cath lab.

The new Boomerang Catalyst System along with the innovative supporting resources in Cardiva's Pathway Program has received a very positive response from cardiac centers and is quickly gaining acceptance by physicians across the U.S. "Easy to use, the Boomerang Catalyst System is a significant advancement in the cath lab in terms of enabling rapid hemostasis with early ambulation for nearly all patients without associated complications. The successful early adoption of our product demonstrates that the Catalyst System delivers where other approaches fail, yielding unprecedented clinical safety and economic outcomes," said Augustine Y. Lien, founder, Chairman and Chief Executive Officer of Cardiva Medical.

About the Boomerang Catalyst System

At the end of the percutaneous procedure, the thin Boomerang Catalyst System 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 from inside of the vessel. The proprietary coating on the wire stimulates the coagulation cascade, which combined with the tight seal, accelerates hemostasis.

After dwelling, 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 and can be achieved in the cath lab for diagnostic patients.

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. Cardiva's first product, the Boomerang Wire System, was approved in EU countries and in the US in 2004 and brought to market in 2005. The second generation product, the Boomerang Catalyst System, was approved in March 2007. The company is committed to going beyond closure with the Boomerang Catalyst System which uniquely provides control to achieve rapid hemostasis with early patient ambulation; certainty to leave nothing behind, eliminate implant-related complications and allow immediate re-access; and confidence to deliver superior outcomes with the support and resources of Cardiva's Pathway Program. Because of its unique focus and outstanding technology, Cardiva 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 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 http://www.cardivamedical.com .

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


Source: Cardiva Medical

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