Eclipse Submits PMA Application to FDA for Transmyocardial Revascularization
New Laser Heart Treatment for Angina Sufferers Submitted to FDA
SUNNYVALE, Calif., July 8 /PRNewswire/ -- Eclipse Surgical Technologies, Inc. (Nasdaq:ESTI) today announced that the Company
submitted a Pre-Market Approval (PMA) application to the Food and Drug Administration (FDA) last week. The application requests
FDA approval for use of the Eclipse laser system to treat patients with Class IV angina (chest pain) caused by coronary artery disease in
a procedure called Transmyocardial Revascularization (TMR).
Eclipse presented six month, Phase II data from its randomized study of the safety and efficacy of TMR, as compared to drug therapy for
Class IV angina patients who are considered otherwise inoperable. This data demonstrates improvement in angina symptoms for 92% of
the TMR-treated patients after six months, while only 18% of the patients on drug therapy experienced the same results. The study also
demonstrated a statistically significant reduction in re-hospitalizations. Twelve month Phase I data was provided to the FDA as well.
``We are pleased to announce this encouraging news,'' said Rich Mueller, President and COO of Eclipse. ``While the PMA review
process can be lengthy and uncertain, we are extremely proud of our execution speed in achieving this milestone.''
TMR is a new laser heart treatment in which one millimeter channels are made through the heart muscle itself, redistributing flow of blood
within the muscle. It is believed this procedure encourages new vessel formation, or angiogenesis, and results in a reduction of angina pain.
This new technology is designed to be used after other treatments for coronary artery disease such as bypass surgery or balloon
angioplasty have failed. Eclipse is also conducting clinical trials studying TMR in conjunction with bypass surgery, to treat areas of the
heart not improved by a traditional bypass graft.
TMR is performed by a cardiac surgeon through a small incision in the chest. The Company has also developed a catheter-based version
for use by cardiologists in a procedure called Percutaneous Transluminal Myocardial Revascularization, or ``PTMR.'' This procedure is
performed under local anesthesia by inserting a catheter in the leg artery and creating the laser channels from the inside of the heart.
Eclipse began PTMR clinical studies outside of the U.S. last month and was the first to receive IDE approval from the FDA to begin
clinical trials in the United States of this new, less invasive approach to TMR.
Eclipse received the CE Mark and ISO 9001 certification earlier this year, allowing international marketing of the Company's laser
systems and disposable fiber-optic handpieces.
Eclipse is a medical device company specializing in cardiac revascularization products for the treatment of advanced cardiovascular
disease. Eclipse has pioneered and refined the use of laser-based surgical products and disposable fiberoptic accessories for TMR and
PTMR. TMR and PTMR are investigational procedures that may be performed on a beating or non-beating heart using a special holmium
laser device to create pathways within the heart muscle. Eclipse must obtain marketing clearance (PMA) from the FDA before its
products for TMR and PTMR can be offered on a commercial basis in the United States.
NOTE: Any forward looking statements in this news release are based on current expectations and beliefs and are subject to numerous
risks and uncertainties that could cause the actual results to differ materially. Factors that could cause actual results to differ materially
include uncertainties associated with clinical trials, no assurance of market acceptance, no assurance of FDA approval, no assurance of
third-party reimbursement of procedure costs, dependence on a single product line, potential third-party patent infringement claims and
uncertainty regarding production of proprietary technologies, as well as additional risk factors, as discussed in the ``Risk Factors'' section
of Eclipse's Annual Report on Form 10-K dated December 31, 1996, and Eclipse's quarterly reports filed with the U.S. Securities
Exchange Commission (SEC). |
