FDA SETS ADVISORY PANEL DATE OF OCTOBER 2 FOR LACI REVIEW.

The Spectranetics Corporation (NASDAQ:SPNC), Colorado Springs, has announced that the FDA has set the date of October 2, 2003 for a Circulatory System Devices Advisory Panel review of the company's Pre-Market Approval (PMA) Supplement based on its LACI (Laser Angioplasty to treat Critical Limb Ischemia) pivotal trial.

John G. Schulte, president and chief executive officer, stated, "A panel review of the LACI trial data was expected and is consistent with the FDA's published guidelines for new indications. Given the strength of the data we submitted, we are hopeful that when the panel reviews the LACI data, it will recommend approval. In light of this established panel date, we are growing more confident that if approved, we will be positioned to market our products for the LACI indication by year end."

Critical Limb Ischemia (CLI) is the most severe manifestation of atherosclerotic disease of the lower extremities. Approximately 15-30% of patients with lower extremity arterial disease will progress from intermittent claudication (leg pain) to CLI over the course of their disease. This translates to an estimated population of between 1.5 and 2.0 million CLI patients in the United States and Europe, which represents an estimated addressable market for the LACI indication that is in excess of $300 million annually.

CLI is associated with multi-level arterial disease in the thigh all the way down to the arteries near the ankle and is dominated by occlusions (total blockages) rather than stenoses (partial blockages). The extent and location of the disease make arterial reconstruction, including surgery and balloon angioplasty, difficult. The LACI trial showed that CLI patients who were poor surgical candidates can be successfully treated with laser assisted therapy. The primary endpoint of six-month survival with limb salvage was achieved in 93% of the limbs (legs) treated, compared with 87% in the control group. Additionally, surgery was performed in 2% of the LACI group compared with 34% in the control group.

About Spectranetics

Spectranetics is a medical device company that develops, manufactures and markets single-use medical devices used in minimally invasive surgical procedures within the cardiovascular system in conjunction with its proprietary excimer laser system. The company's CVX-300(R) excimer laser is the only system approved by the FDA for multiple cardiovascular procedures, including coronary atherectomy, the treatment of in-stent restenosis prior to radiation therapy and the removal of problematic pacemaker and defibrillator leads. The company recently completed the LACI (Laser Angioplasty for Critical Limb Ischemia) clinical trial for laser atherectomy to improve circulation to the lower leg. The LACI trial data have been submitted to the FDA and the company anticipates FDA approval in late 2003. Nearly all of the company's FDA-approved and investigational applications have received Communautes Europeennes (CE) mark registration for marketing within Europe.

For more information, call 719/633-8333 or visit http://www.spectranetics.com.