SUNNYVALE, Calif.--Jan. 13, 1999--InnerDyne, Inc. (NASDAQ NM: IDYN) today reported the acceptance by the U.S. Food & Drug Administration (FDA) of the company's 510(k) premarket notification based on the demonstrated safety and clinical performance of the Step™ line of minimally invasive surgical access devices and based on InnerDyne's proprietary radial dilation technology. The product safety premarket notification resulted from the submittal of substantial information related to the comparative safety of the Step radially expanding dilation technology for surgical access versus standard cutting trocars.
The FDA clearance acknowledges that the Step radially expanding surgical access technology has been shown in independent clinical comparative studies versus conventional cutting trocars to provide safety benefits including, but not limited to:
(1.) a lower prevalence of abdominal wall bleeding, (2.) a lower prevalence of bowel and bladder injuries, (3.) a lower incidence of post operative incisional hernias, and (4.) a lower prevalence of major vascular injury.
In addition, a substantial number of patients reported reduced pain from Step access sites when compared to conventional trocar sites.
William G. Mavity, InnerDyne president and CEO, commented, "We are extremely pleased to have received clearance of this 510(k) notification, following significant review by the FDA of the numerous independent clinical studies which the Company submitted in support of this application. The ability of the Step system to significantly reduce the most common complications associated with traditional sharp trocar entry, while providing procedure benefits and reducing access site pain, clearly differentiates InnerDyne's offering from traditional access devices. We believe this clearance will become an important strategic tool that will significantly enhance our efforts to gain increased product acceptance in the face of entrenched competition that aggressively leverages broad product bundling agreements.''
InnerDyne, Inc., designs, develops, manufactures and commercializes minimally invasive surgical access products incorporating its proprietary radial dilation technology. The Company is evaluating the application of its radial dilation technology to enhance percutaneous access for interventional vascular procedures. The Company has proprietary technology in the areas of thermal ablation and biocompatible coatings, which it intends to continue to develop either internally or through strategic alliances. InnerDyne, Inc. common stock is traded on the Nasdaq National Market under the symbol IDYN.
Except for the historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties, including those risks detailed from time to time in InnerDyne's SEC reports, including its Annual Report on Form 10-K for the year ended December 31, 1997, and its Form 10-Q for the quarter ended September 30, 1998 as filed with the Securities and Exchange Commission.
Contact:
InnerDyne, Inc.
William G. Mavity, President & CEO
Robert A. Stern, Vice President & CFO
408/745-6010
or
Investor Relations:
Lippert/Heilshorn & Associates
Bruce Voss, 310/575-4848
Ruth Abeshaus, 212/838-3777