COLORADO SPRINGS, Colo., Jan. 13 /PRNewswire/ -- The U.S. Food and Drug
Administration (FDA) has granted The Spectranetics Corporation (Nasdaq: SPNC)
510(k) clearance to market a new product for interventional cardiovascular
therapy, the Spectranetics Support Catheter.
The Spectranetics Support Catheter is designed for use in the
cardiovascular system for accessing and/or crossing lesions. The primary
function is to provide support to an angioplasty guidewire.
The Support Catheter complements Spectranetics' array of other
one-time-use products for interventional cardiovascular therapy. The Company
plans to begin marketing the Support Catheter during the current quarter and
believes it is a high-margin product in a market estimated at
30,000 procedures annually.
"The Support Catheter represents yet another high-quality product from our
engineering team. Within a very short period, the team has developed the
support catheter to address a unique problem," said Joseph A. Largey,
Spectranetics' President and CEO. "Spectranetics is committed to continue to
refine and build upon its line of high-quality devices for interventional
therapy that help meet key medical needs."
The Support Catheter and the recently approved lead locking device
(LLD(TM)), unlike many of Spectranetics' products, are not excimer-laser based
technologies. The Support Catheter and the LLD are also the first products
from the Company to be approved through the FDA's 510(k) regulatory approval
process, which is generally a faster approval process.
Spectranetics is a medical device company engaged in the development,
manufacturing, marketing and distribution of its technology for interventional
cardiovascular therapy. The Company's CVX-300(R) excimer laser system is the
only excimer laser system approved by the FDA for multiple cardiovascular
procedures. The technology has been designed for use in multiple
cardiovascular applications, including coronary angioplasty and the removal of
pacemaker and ICD leads. The Company is also developing additional
applications for its excimer laser technology in restenosed stents and
peripheral vascular applications.
This news release contains forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Such statements are based on current assumptions that
involve risks and uncertainties that could cause actual outcomes and results
to differ materially. These risks and uncertainties include price and product
competition, dependence on new product development, intellectual property
claims of third parties, availability of inventory from suppliers, market
acceptance of new products, and product defects. For a further list and
description of such risks and uncertainties which could cause the actual
results, performance or achievements of the Company to be materially different
from any future results, performance or achievements, please see the Company's
previously filed SEC reports. Spectranetics disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
Note: Spectranetics and CVX-300 are registered trademarks of The
Spectranetics Corporation.
SOURCE The Spectranetics Corporation
-0- 01/13/2000
/CONTACT: Paul Samek, Chief Financial Officer of The Spectranetics
Corporation, 800-633-0960/ |
