FDA Panel Backs AIS Laser System for Use on Heart : Medicine: Irvine company’s system is the first to be recommended for approval as a tool to open heart blockages without riskier surgery.

Advanced Internventional Systems, a firm founded by physicians from Cedars-Sinai Medical Center in Los Angeles, said Tuesday that its medical laser system has become the first to be recommended for FDA approval for use in opening blocked heart arteries.

The Food and Drug Administration’s Circulatory System Devices Panel recommended approval of the company’s laser system for treating certain kinds of heart blockages. The panel’s recommendation almost always leads to FDA marketing approval.

Susan Mills, AIS marketing director, said the panel recommended the laser system for a limited number of conditions in which balloon angioplasty, which uses pressure to break up plaque inside a blood vessel, doesn’t work well and thus the patient probably would require surgery without a laser alternative.

With the AIS system, laser-produced energy is applied by means of a catheter that is threaded into the coronary arteries, avoiding the need for riskier and more debilitating heart surgery.

Specifically, Mills said, the panel has recommended approval of the company’s “excimer laser angioplasty system” for arterial blockages greater than 20 millimeters in length and for blockages at the origin of major arteries and arterial branches.

Also, the panel has asked for additional follow-up data before issuing a formal letter of approval.

Still, Mills said, AIS officials were “thrilled” by the panel action, which they said came three months ahead of their expectation. Under the recommendation, she said, “about 10% of the people currently treated by alternative methods to bypass surgery could be treated by laser.” She said the company plans to continue clinical tests to broaden the laser’s applications.

FDA approval would give AIS, a privately held company that so far has survived by raising $25 million in venture capital, its first commercial product and its first toehold in the coronary angioplasty marketplace, which generates sales of $375 million a year. The company hopes to obtain marketing approval by early next year.

Mills said the company was founded in 1986 by three physicians from Cedar Sinai--Drs. James Forrester, Frank Litvack and Warren Grundfest--and Jim Laudenslager, a physicist formerly employed at Jet Propulsion Laboratory in Pasadena.

She said they developed the company’s excimer laser system, which since 1988 has been used to treat 1,000 patients in testing centers. While other companies have initially tested their laser systems in legs and arms, she said, AIS decided to concentrate on the heart, where it believes that the excimer laser, which uses a photochemical process to break down plaque in the arteries, is most effective.

She said her company’s closest competitor in the medical laser industry, Spectranetics in Colorado Springs, Colo., is “probably nine months to a year behind us” in getting FDA marketing approval for coronary use.

A second competitor, Trimedyne Inc. of Tustin, is even further behind in the race for coronary approval. Howard Cooper, Trimedyne’s chief executive, said Tuesday that it will be two to three years before the company can hope to get FDA approval of heart operations for any of its lasers.