Spectranetics scores CE mark for PAD drug-coated balloon

Stellarex drug-coated angioplasty balloon--Courtesy of Spectranetics

Spectranetics picked up a CE mark for an even smaller iteration of its drug-coated angioplasty balloon. This one is designed to treat small vessels, below-the-knee peripheral artery disease (PAD) and critical limb ischemia (CLI).

The new 0.014” Stellarex balloon joins a 0.035” version, which earned the CE mark in 2014. The Stellarex technology is not licensed in the U.S. The balloon uses the company’s EnduraCoat tech to prevent drug loss while deploying the device and to enable controlled drug delivery at the treatment site.

PAD affects as many as 9 million people in the U.S. and is caused by the narrowing of blood vessels that limit blood flow to the limbs. People with PAD may or may not experience symptoms, the most common of which is pain in the legs.

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CLI, which affects more than 3 million people in the U.S. and Europe, is characterized by severe blockage of the arteries that significantly restricts blood flow to the extremities. It can cause severe pain and skin ulcers. With the new Stellarex drug-coated balloon, Spectranetics hopes to improve outcomes for CLI patients by warding off restenosis, which frequently occurs within three to six months following treatment. Restenosis in CLI patients can lead to wounds not healing, the need for reintervention and amputation.

"Spectranetics is committed to providing specialized and innovative tools and compelling clinical data to improve our patients’ quality of life,” said CEO Scott Drake in a statement. “Stellarex 0.014” exemplifies these important elements and augments our existing product portfolio, which now includes clinically differentiated treatment for both above and below the knee disease. The Stellarex 0.014” DCB is a significant advancement in our effort to eradicate restenosis and amputation.”

It has been a big week for PAD: On Tuesday, Shockwave Medical bagged a $45 million Series C financing for its lithoplasty balloon. The device combines angioplasty with lithotripsy, or the delivery of ultrasound pulses, to break up arterial plaque.

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