Eclipse Surgical Seeks FDA Approval of a Heart Laser Device

Eclipse Surgical Technologies on Tuesday said it filed an application for Food and Drug Administration approval of its laser heart device on the basis of strong trial results.

Shares in Sunnyvale, Calif.-based Eclipse rose 19 cents to $8.50 in trading Tuesday.

The application’s timely filing is encouraging, said Rich Mueller, Eclipse president and chief operating officer. “We are extremely proud of our execution speed in achieving this great milestone,” Mueller said.

The laser was designed to treat patients with angina, a condition characterized by crushing chest pain. It reduced the symptoms in 92% of patients in a random six-month study. Only 18% of patients receiving drug therapy showed the same improvement. The study also showed lower rates of rehospitalization in patients receiving the laser treatment.

The laser is used in patients whose hearts are too weak or who have already undergone invasive surgery.

The procedure, transmyocardial revascularization or TMR, is designed for patients whose angina is caused by blocked arteries. A surgeon uses the laser to drill small holes in the patient’s heart. The heart then creates new channels so that blood can get around blocked arteries, sending more blood to oxygen- starved tissue.

CardioGenesis Corp. and PLC Laser Systems Inc. are two other companies developing TMR lasers. PLC’s laser is scheduled for FDA panel review at the end of this month.