General Surgical Innovations Announces FDA Clearance of SAPHtrak Balloon; Balloon Aids Minimally Invasive Removal of the Saphenous Vein for Use in Bypass Procedures.

PALO ALTO, Calif.--(BW HealthWire)--Feb. 24, 1997--General Surgical Innovations, Inc. (Nasdaq: GSII) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market the Spacemaker(R) SAPHtrak(TM) balloon dissection system to aid minimally invasive removal of the saphenous vein.

In the new procedure, the SAPHtrak balloon dissector allows surgeons to create a working space by separating tissue planes to provide access to the surgical site. Once this space has been established, surgeons remove the vein using standard minimally invasive surgical tools and use these veins for Coronary Artery Bypass Graft (CABG) and peripheral vascular bypass procedures. Today's clearance represents GSI's first and most important part of a minimally invasive saphenous vein harvesting kit which the Company plans to introduce in calendar 1997.

"The availability of appropriate instruments to facilitate the minimally invasive harvest of the saphenous vein is a major breakthrough for patients and their surgeons. GSI's SAPHtrak dissector is designed to avoid the long incision over the saphenous vein in traditional procedures, which is typically associated with an appreciable incidence of infection and wound breakdown," stated Dr. Thomas O'Donnell, President and CEO, former Surgeon-in-Chief of New England Medical Center, Professor of Surgery, Tufts University School of Medicine. "Patients may benefit from earlier and less painful ambulation and an expected reduction in hospital stay. Critical to the technique is the creation of a consistent working space wherein the vein can be dissected and the tributaries interrupted. The GSI Spacemaker balloon gently and rapidly creates a working space to carry out the minimally invasive vessel harvest."

"While much attention has been focused on CABG procedures using minimally invasive techniques, we know that in many cases patients complain more about the leg pain due to saphenous vain harvesting than the chest pain," stated Roderick A. Young, President and Chief Executive Officer of GSI. "We believe that innovations such as the SAPHtrak balloon dissector are responsive to market needs and represent the next wave in applications of minimally invasive surgical procedures."

More than 600,000 coronary bypass procedures were performed worldwide in 1996 and approximately 90% of these used the saphenous vein as the bypass conduit. Traditionally, the vein is harvested by making an incision which can span the entire length of the leg from ankle to groin. The SAPHtrak balloon dissector allows the vein to be removed through a small number of one to three centimeter incisions. The balloon is inserted through one such incision and then inflated to create an operating space subcutaneously along the length of the saphenous vein.

GSI's Spacemaker balloon dissection systems can rapidly and atraumatically create surgical working spaces by separating natural tissue planes without resorting to blunt dissections used in conventional open surgery and minimally invasive surgery conducted outside of a natural body cavity. In Spacemaker balloon dissection procedures, the balloon dissection system is inserted uninflated between tissue layers through a small incision. The balloon is then filled to a specific volume with air or saline, causing the desired dissection of the tissue planes. The system is then removed and the dissected space can be insufflated with gas to create a surgical working space. Potential advantages of these techniques include reduced patient trauma and blood loss, shorter procedure and patient recovery times and ultimately lower medical costs.

Headquartered in Palo Alto, California, General Surgical Innovations, Inc. develops, manufactures, and sells balloon dissection systems for minimally invasive surgery. The Company's products are specifically designed for endoscopic and laparoscopic techniques for use in general, vascular, cosmetic and reconstructive surgeries to create a working space at the surgical site, minimize tissue damage and improve patient recovery time. The Company has developed a broad range of balloon shapes and sizes to be used for various surgical techniques, procedures, and market segments. In addition to selling products through corporate partners, GSI also sells products directly into the vascular surgery and cosmetic and reconstructive surgery markets. -0-

Except for historical information contained herein, the matters discussed in this press release are forward-looking statements, the accuracy of which is necessarily subject to risks and uncertainties. The clinical efficacy of and market demand for the SAPHtrak balloon dissector and GSI's other products, among other matters discussed in this release, may differ significantly from the discussion of such matters in the forward-looking statements. Such differences may be based upon factors within General Surgical Innovations' control, such as strategic planning decisions by management and reallocation of internal resources, or on factors outside of General Surgical Innovations' control, such as scientific advances by third parties, introduction of competitive products and delays by regulatory authorities, as well as those factors set forth under the heading "Factors Affecting Future Results" in General Surgical Innovations' Prospectus, Form 10K for the year ended June 30, 1996, Form 10Q for the quarters ended September 30, 1996 and December 31, 1996 and other securities filings of the Company.

CONTACT: General Surgical Innovations, Inc.

Stephen J. Bonelli, CFO/VP Finance, 415/812-9730

[e-mail]

or

Burns McClellan, Inc.

Justin Jackson (Media) or

Jonathan M. Nugent (Investors), 212/505-1919