Medical Device Daily

AngioScore (Fremont, California) stroked a regulatory base hit in September 2004 with its CE mark to launch its flagship product, the AngioSculpt, in Europe.

A year later the company smacked a home run when it obtained FDA 510(k) clearance to market the scoring balloon catheter in the U.S. peripheral artery disease (PAD) market.

Now, the company has blasted a grand slam by getting Premarket Approval (PMA) to sell the device for the treatment of coronary artery disease (CAD).

“The PMA opens up a whole new ballgame for us in the U.S. market,” Thomas Trotter, CEO of AngioScore, told Medical Device Daily.

Trotter said some 600,000 to 800,000 PAD cases are performed in the U.S. each year, but to market the device for coronary artery disease required a PMA. The company estimates there are roughly 1.5 million angioplasty procedures done a year worldwide to treat CAD.

Designed to be an improved angioplasty catheter for complex lesions, the AngioSculpt is comprised of a semi-compliant angioplasty balloon surrounded by a scoring element, which is intended to work in tandem with the balloon to deliver a scoring effect to the target lesion upon balloon inflation. As the balloon inflates, the radial forces are concentrated along the surfaces of the nitinol scoring element, which results in luminal expansion that is precise, predictable, and controlled, according to AngioScore.

With a “plane old balloon angioplasty”, or POBA as Trotter calls it, physicians compress the plaque against the sides of the artery walls. What has changed, he said, is that in the early years of using balloon angioplasty catheters, physicians only used the devices in simple procedures for what are known as type A lesions because they hadn’t been around very long.

Today, he said, the instruments are being used for much more difficult and complex lesions but the devices themselves had not changed much in the last 20 years.

Trotter said the PMA means the AngioSculpt has been judged safe and effective for type C lesions. “In our U.S. clinical trial 76% of the lesions treated in that trial were classified as type B2 or C, which are the most complex, difficult lesions facing physicians who perform angioplasty procedures”

“Yet even in this very challenging clinical trial, the AngioSculpt achieved a procedural success rate of 98.5% and a cumulative freedom from MACE [major adverse cardiac events] of 97.5% at follow-up, highlighting the excellent safety profile of this product,” said Gary Gershony, MD, AngioScore’s chief medical officer.

Also, Trotter added, the U.S. clinical trial had a dissection rate — irregular tears and splits during the procedure —of 13.7%, compared to a standard trial using a POBA in which dissection rates have been reported as high as 30% or more, even for type A or B lesions.

The U.S. multi-center clinical trial was a prospective study evaluating the safety and effectiveness of the AngioSculpt in 200 patients with single or multiple vessel coronary artery disease, in both de novo lesions and in-stent restenosis lesions, AngioScore said.

The device was developed by a design engineer and a physician who are both still involved with the company, “who actually came up with this idea of adding a scoring element that has led to all these great outcomes,” Trotter said.

In September 2005, AngioScore obtained FDA 510(k) clearance to market the AngioSculpt in the U.S. for balloon dilatation of lesions in infra-popliteal arteries, one of the key segments of the PAD market. The company was granted the CE Mark for the AngioSculpt allowing the product to be sold in Europe and the Middle East in 2004.

Trotter said the next step for the company is to make longer and larger balloons to be used in procedures involving larger above-the-knee vessels, between the knee and the hip. Until now, AngioScore’s devices have been designed for smaller, below-the-knee vessels.

But perhaps even more exciting, Trotter said, is that the company is also working on bringing a drug-coated angioscope to the PAD market — as perhaps an alternative to drug-eluting stents — “to deliver the drug probably a lot better than a stent.”

“Earning a PMA for the AngioSculpt is a major step forward for AngioScore,” he said. “We expect 2007 to be a very significant year for the AngioSculpt as we ramp-up our sales efforts around the world.”