Mark,
SPNC product WAS APPROVED by FDA.
Read it here.
ESTI product WAS NOT APPROVED yet .
DENVER, Feb. 24 /PRNewswire/ -- The Spectranetics Corporation,
(Nasdaq: SPNC) manufacturer of the only medical excimer laser market-approved
by the FDA for interventional treatment of cardiovascular disorders, outlined
the expanded market for its technology at the "Know Your Colorado Companies"
symposium today.
Since 1993, the CVX-300 excimer laser has been used to treat severe
blockages of coronary arteries, alone or in conjunction with traditional
balloon angioplasty. Under a new management team led by President and Chief
Executive Officer, Joseph A. Largey, Spectranetics has expanded its technology
into new cardiovascular markets that provide minimally invasive treatment
options for cardiovascular patients.
-- Excimer laser removal of non-functioning and problem pacemaker and
implanted defibrillator (ICD) leads. Non-functioning pacemaker and implanted
defibrillator leads (wires that connect the pacemaker to the heart) represent
a growing medical problem. Because of the danger of life-threatening
infections and other complications, many leads -- potentially 10% -- will
eventually need to be removed. With FDA market release in December 1997 of
the Spectranetics excimer laser approach to lead removal, which proved 94%
effective in trials, patients and physicians now have an alternative to major
surgical interventions. The estimated market potential for lead removal today
is in excess of $75 million annually.
-- Excimer laser clearing of stents. Stents (metallic scaffolds inserted
in coronary arteries to hold them open) have become one of the fastest growing
treatment alternatives in interventional cardiology today. More than 230,000
stents were deployed in patients in 1997, and that number is growing at 20%
annually. With up to 30% of stents, tissue buildup (restenosis) occurs,
requiring re-intervention. In January 1998, Spectranetics received the TUV
mark of approval in Europe to use its excimer laser catheters to clear
obstructed stainless steel stents.
-- Excimer laser clearing of peripheral blockages. Spectranetics is also
targeting use of its excimer laser for treating obstructed leg, or peripheral,
arteries as an alternative to femoral bypass surgery or amputation.
-- Transmyocardial revascularization (TMR). This experimental procedure
uses lasers to create small holes in oxygen-starved heart muscles to stimulate
growth of new blood vessels in patients with limited treatment options.
Through a strategic partnership, United States Surgical Corporation will
purchase Spectranetics laser systems and disposables for use in TMR
procedures.
The Spectranetics revenue model is driven by sales of high-margin, single-
use, disposable laser catheters for use with the company's large installed
base of approximately 250 excimer lasers worldwide. Management has focused
its direct sales force and clinical support team on building the base of
clinical data; physician training in the use of the excimer laser and pursuing
additional cardiovascular applications.
SOURCE The Spectranetics Corporation
/CONTACT: Jan Morton of The Spectranetics Corporation, 719-633-8333/
(SPNC) |
