Healthcare Industry News:  anastomosis 

Devices Cardiology Distribution

 News Release - September 7, 2006

ATS Medical Signs Exclusive Distribution Agreement with Novare Surgical Systems, Inc. for Enclose II(R) for Cardiac Surgery

MINNEAPOLIS, Sept. 7 (HSMN NewsFeed) -- ATS Medical, Inc. (Nasdaq: ATSI ) -- developer, manufacturer and marketer of a wide variety of cardiac surgery products and services, today announced an exclusive distribution agreement with Novare Surgical Systems, Inc. for Novare's Enclose IIŪ cardiac anastomosis assist device. ATS Medical will distribute the device in the United States, Germany, France and the United Kingdom.

The Enclose II anastomosis assist device is used by cardiac surgeons to attach a bypass vessel to the aorta during coronary artery bypass graft (CABG) surgery. It is estimated that more than 800,000 CABG procedures are performed worldwide each year.

ATS Medical President, CEO and Chairman of the Board Michael D. Dale noted, "Our exclusive distribution agreement with Novare Surgical Systems is another step towards our goal of becoming a more diversified cardiac surgery business through new business development. The Enclose II device broadens our product offerings and allows us greater opportunities to support cardiac surgeons in the treatment of structural heart disease. We can more optimally leverage the call points, purchasing pathways and sales, marketing and distribution infrastructure that we have successfully developed. The Enclose II is an innovative and proprietary option for cardiac surgeons that can help them reduce risk for their patients undergoing coronary bypass surgery. We are excited about the prospects for our collaboration with Novare."

"Novare has been looking for a stable, cardiac surgeon-friendly marketing partner for some time," added Kerry Pope, President and CEO of Novare Surgical Systems. "Our customers will receive the benefit of ATS Medical's premiere sales and marketing organization bringing innovative products like Enclose II to them."

The Enclose II anasotomosis assist device was designed for on-pump and off-pump (or "beating heart") CABG procedures. Its handheld nature allows the cardiac surgeon to create an enclosed bloodless field approximately one centimeter square in the fully pressurized aorta without the necessity of a side-biting, partial occlusion clamp. Partial occlusion clamping has been associated with a variety of post-operative complications, possibly due to the release of plaque from the aorta vessel walls. Enclose II was redesigned from the original Enclose I device to improve its functionality and ease of handling for the surgeon.

With the Enclose II device, the surgeon creates a sutured connection, or proximal anastomosis, of a vein or arterial graft to the aorta using standard suturing techniques. Unlike connector technology that eliminates both the side-biting clamp and the traditional anastomosis technique, the Enclose II device preserves the well-documented high-patency rates and hemodynamics of hand-sutured proximal anastomoses. The Enclose technology has been used by cardiac surgeons in more than 15,000 procedures for bypass connection without reported adverse events and was developed by renowned surgeon and inventor Thomas J. Fogarty, M.D.

Novare Surgical Systems is based in Cupertino, California. It was founded in 1999 to develop, manufacture and market devices for tissue manipulation during cardiovascular, thoracic and peripheral vascular surgery. The company's web site is http://www.novaresurgical.com .

About ATS Medical

ATS Medical, Inc. manufactures and markets products and services focused on cardiac surgery. The company, global in scope, has been headquartered in Minneapolis since its founding in 1991. More than 130,000 ATS Open PivotŪ Heart Valves, which utilize a unique pivot design resulting in exceptional performance and low risk profile, have been implanted in patients worldwide. ATS Medical's focus on serving the cardiac surgery community is further strengthened by offerings that include ATS Simulus(TM) annuloplasty products for heart valve repair, Surgi-FrostŪ and Frost-Byte(TM) products for surgical cryoablation of cardiac arrhythmias, RTI-Cardiovascular for allograft tissue services, QAS home monitoring services for anticoagulation therapy and the development of PARSUS blood filtration technology. The ATS Medical web site is http://www.atsmedical.com .

Safe Harbor

This Press Release contains forward-looking statements that may include statements regarding intent, belief or current expectations of the Company and its management. Actual results could differ materially from those projected in the forward looking statements as a result of a number of important factors, including regulatory actions, competition, pricing pressures, supplier actions and management of growth. For a discussion of these and other risks and uncertainties that could affect the Company's activities and results, please refer to the Company's filings with the Securities and Exchange Commission including its Form 10-K for the year ended December 31, 2005, as amended.


Source: ATS Medical

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