The Spectranetics Corporation has filed a Pre-Market Approval (PMA) Supplement with the U.S. Food and Drug Administration (FDA) containing clinical data from the LACI (Laser Angioplasty to treat Critical Limb Ischemia) Phase II trial.
John G. Schulte, president and chief executive officer, commented, "We are pleased to submit this important filing to the FDA on schedule.The data gathered from the pivotal clinical trial are excellent, and we are hopeful for a pre-market approval in late 2003."
The LACI trial enrolled 145 patients (155 limbs) at 14 domestic and several European sites.Data from the LACI trial will be compared with a control group consisting of 789 patients with critical limb ischemia treated with a variety of standard therapies.Outcomes for the control group were published in The Annals of Internal Medicine vol. 130 pp. 412-421, (1999). Study data showed that 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, significant adverse events in treated patients were nearly one-half that of the control group at 33% and 60%, respectively.
A PMA supplement typically has a six to nine month review time.However, a panel review and/or questions regarding the filing can extend the review time by at least an additional six months.If no extensive questions arise, the company continues to expect approval in late 2003, which is consistent with previous guidance.
The company estimates a worldwide addressable market in excess of $200 million annually, which contains over 80,000 amputations performed annually in the United States.The LACI Phase II trial enrolled patients who were considered to be poor surgical candidates 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 necrotic, gangrenous tissue on the foot or lower leg that requires minor amputation (Rutherford categories 4, 5, and 6). Enrollment began in April 2001 and was completed in April 2002.The trial included the use of coronary catheters as well as larger diameter catheters ranging from 2.2 to 2.5 millimeters.