First LACI Phase 2 Patient Treated With Excimer Laser Angioplasty For Circulatory Problems to the Lower Leg

Apr 19, 2001, 01:00 ET from Spectranetics Corporation

    COLORADO SPRINGS, Colo., April 19 /PRNewswire/ -- In an effort to solicit
 investigators for the LACI Phase 2 registry (Laser Angioplasty for Critical
 limb Ishemia), The Spectranetics Corporation (Nasdaq: SPNC) today announced
 that John W. Shuck, M.D., of the Main Line Health Heart Center at Lankenau
 Hospital in the Philadelphia area, treated the first LACI Phase 2 patient on
 April 13, 2001.  The LACI Phase 2 trial is intended to demonstrate the safety
 and efficacy of excimer laser angioplasty to treat circulatory problems of the
 lower leg.
     The patient was a 76-year-old man who had been experiencing leg pain for
 three weeks, even while resting.  The patient has a history of cardiovascular,
 cerebrovascular and peripheral vascular disease.  He presented with a 4 cm.
 occlusion of the main artery in the thigh, the superficial femoral artery, as
 well as obstructions blocking the flow in other arteries down the leg -- the
 popliteal, tibioperoneal trunk and peroneal arteries.  All four arteries were
 treated in a minimally invasive procedure with excimer laser angioplasty,
 followed by balloon angioplasty and the implantation of stents (supporting
 metal mesh tubes).  The patient left the hospital the next day with no leg
 discomfort.
     Dr. Shuck commented:  "I chose excimer laser angioplasty because my prior
 experience with LACI Phase 1 and the PELA trial, which involves arteries in
 the upper leg, has convinced me that excimer laser angioplasty works to clear
 occlusions and obstructions in leg arteries with minimal trauma to the vessel
 and to the patient.  Furthermore, given the patient's other medical problems,
 he was a poor candidate for a more invasive surgical treatment."
     Joseph A. Largey, president and chief executive officer of Spectranetics,
 commented:  "We're delighted to have our first patient enrolled in LACI Phase
 2, and intend to keep this clinical trial on a fast track.  Our current
 schedule calls for enrollment to be complete within the next 12 months, with
 FDA approval anticipated in 2003.  We estimate the market potential for
 peripheral angioplasty in the legs at more than $600 million."
     The LACI Phase 2 trial enrolls patients with circulatory problems of the
 lower leg evidenced by leg pain, even while resting; non-healing ulcers on the
 foot or lower leg; or areas of dead, gangrenous tissue on the foot or lower
 leg that require minor amputation.  The trial will ultimately involve up to
 167 patients at 20 domestic and several European sites.  Enrollment is
 anticipated to be complete within the next 12 months.
     Located in Philadelphia's western suburbs, the Main Line Health Heart
 Center is a partnership of Main Line Health, including acute care hospitals
 Lankenau, Bryn Mawr, and Paoli Memorial, and its cardiovascular physicians.
 Dedicated to the prevention and treatment of heart disease, its activities
 include cardiovascular research, community and medical education, and program
 development.  Its mission is to reduce the impact of heart and vascular
 disease and improve quality of life.  The LACI Phase 2 study will take place
 on the Heart Center's Lankenau Hospital campus.
     Spectranetics is a medical device company that develops, manufactures and
 markets products that deliver excimer laser energy for minimally invasive
 surgical procedures within the cardiovascular system.  The company's CVX-
 300(R) excimer laser is the only system approved by the Food and Drug
 Administration (FDA) for multiple cardiovascular procedures, including
 coronary angioplasty and the removal of problematic pacemaker and
 defibrillator leads.  The company is currently conducting three
 investigational trials designed to obtain FDA approval to market products in
 the United States for additional applications.  The LACI study (Laser
 Angioplasty for Critical Ischemia) tests laser angioplasty to improve
 circulation to the lower leg.  The PELA trial (Peripheral Excimer Laser
 Angioplasty) deals with blockages in arteries in the upper leg.  LARS (Laser
 Angioplasty for Restenosed Stents) tests use of excimer laser energy to clear
 blocked coronary stents (thin steel mesh tubes used to support the walls of
 coronary arteries).  All of the company's FDA-approved and investigational
 applications have received Communaute Europeene (CE) mark registration for
 marketing within Europe.
     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 may include increasing
 price and product competition, uncertain success of the company's strategic
 direction, dependence on new product development, intellectual property claims
 of third parties, availability of inventory from suppliers, timeliness of FDA
 approval to market new products or applications, market acceptance of new
 products or applications, 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 anticipated results, performance or achievements, please see the
 company's previously filed SEC reports.  Spectranetics disclaims any intention
 or obligation to update or revise any financial projections or forward-looking
 statements, whether as a result of new information, future events or
 otherwise.
     Spectranetics and CVX-300 are registered trademarks of The Spectranetics
 Corporation.
 
 

SOURCE Spectranetics Corporation
    COLORADO SPRINGS, Colo., April 19 /PRNewswire/ -- In an effort to solicit
 investigators for the LACI Phase 2 registry (Laser Angioplasty for Critical
 limb Ishemia), The Spectranetics Corporation (Nasdaq: SPNC) today announced
 that John W. Shuck, M.D., of the Main Line Health Heart Center at Lankenau
 Hospital in the Philadelphia area, treated the first LACI Phase 2 patient on
 April 13, 2001.  The LACI Phase 2 trial is intended to demonstrate the safety
 and efficacy of excimer laser angioplasty to treat circulatory problems of the
 lower leg.
     The patient was a 76-year-old man who had been experiencing leg pain for
 three weeks, even while resting.  The patient has a history of cardiovascular,
 cerebrovascular and peripheral vascular disease.  He presented with a 4 cm.
 occlusion of the main artery in the thigh, the superficial femoral artery, as
 well as obstructions blocking the flow in other arteries down the leg -- the
 popliteal, tibioperoneal trunk and peroneal arteries.  All four arteries were
 treated in a minimally invasive procedure with excimer laser angioplasty,
 followed by balloon angioplasty and the implantation of stents (supporting
 metal mesh tubes).  The patient left the hospital the next day with no leg
 discomfort.
     Dr. Shuck commented:  "I chose excimer laser angioplasty because my prior
 experience with LACI Phase 1 and the PELA trial, which involves arteries in
 the upper leg, has convinced me that excimer laser angioplasty works to clear
 occlusions and obstructions in leg arteries with minimal trauma to the vessel
 and to the patient.  Furthermore, given the patient's other medical problems,
 he was a poor candidate for a more invasive surgical treatment."
     Joseph A. Largey, president and chief executive officer of Spectranetics,
 commented:  "We're delighted to have our first patient enrolled in LACI Phase
 2, and intend to keep this clinical trial on a fast track.  Our current
 schedule calls for enrollment to be complete within the next 12 months, with
 FDA approval anticipated in 2003.  We estimate the market potential for
 peripheral angioplasty in the legs at more than $600 million."
     The LACI Phase 2 trial enrolls patients with circulatory problems of the
 lower leg evidenced by leg pain, even while resting; non-healing ulcers on the
 foot or lower leg; or areas of dead, gangrenous tissue on the foot or lower
 leg that require minor amputation.  The trial will ultimately involve up to
 167 patients at 20 domestic and several European sites.  Enrollment is
 anticipated to be complete within the next 12 months.
     Located in Philadelphia's western suburbs, the Main Line Health Heart
 Center is a partnership of Main Line Health, including acute care hospitals
 Lankenau, Bryn Mawr, and Paoli Memorial, and its cardiovascular physicians.
 Dedicated to the prevention and treatment of heart disease, its activities
 include cardiovascular research, community and medical education, and program
 development.  Its mission is to reduce the impact of heart and vascular
 disease and improve quality of life.  The LACI Phase 2 study will take place
 on the Heart Center's Lankenau Hospital campus.
     Spectranetics is a medical device company that develops, manufactures and
 markets products that deliver excimer laser energy for minimally invasive
 surgical procedures within the cardiovascular system.  The company's CVX-
 300(R) excimer laser is the only system approved by the Food and Drug
 Administration (FDA) for multiple cardiovascular procedures, including
 coronary angioplasty and the removal of problematic pacemaker and
 defibrillator leads.  The company is currently conducting three
 investigational trials designed to obtain FDA approval to market products in
 the United States for additional applications.  The LACI study (Laser
 Angioplasty for Critical Ischemia) tests laser angioplasty to improve
 circulation to the lower leg.  The PELA trial (Peripheral Excimer Laser
 Angioplasty) deals with blockages in arteries in the upper leg.  LARS (Laser
 Angioplasty for Restenosed Stents) tests use of excimer laser energy to clear
 blocked coronary stents (thin steel mesh tubes used to support the walls of
 coronary arteries).  All of the company's FDA-approved and investigational
 applications have received Communaute Europeene (CE) mark registration for
 marketing within Europe.
     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 may include increasing
 price and product competition, uncertain success of the company's strategic
 direction, dependence on new product development, intellectual property claims
 of third parties, availability of inventory from suppliers, timeliness of FDA
 approval to market new products or applications, market acceptance of new
 products or applications, 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 anticipated results, performance or achievements, please see the
 company's previously filed SEC reports.  Spectranetics disclaims any intention
 or obligation to update or revise any financial projections or forward-looking
 statements, whether as a result of new information, future events or
 otherwise.
     Spectranetics and CVX-300 are registered trademarks of The Spectranetics
 Corporation.
 
 SOURCE  Spectranetics Corporation