Spectranetics wins CE Mark for smaller Stellarex DCB

Spectranetics (NSDQ:SPNC) said yesterday that it won CE Mark approval in the European Union for a smaller size of its Stellarex drug-coated balloon.

The Stellarex 0.014” device is designed to treat small vessels, below-the-knee disease and challenging critical limb ischemia. The larger, 0.035” device won CE Mark approval in December 2014, just before Spectranetics paid Covidien $30 million deal for the angioplasty platform following the consummation of Medtronic‘s (NYSE:MDT) $50 billion merger with Covidien.

The Colorado Springs-based company filed for pre-market approval from the FDA for Stellarex earlier this month, based on 1-year data from its pivotal Illumenate study.

“Spectranetics is committed to providing specialized and innovative tools and compelling clinical data to improve our patients’ quality of life. 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,” president & CEO Scott Drake said in prepared remarks.

The new size means the platform “represents a latest generation DCB backed by compelling evidence in the fem-pop arteries. It holds strong promise to deliver safety and efficacy in the notoriously challenging infrapopliteal district,” added Professor Dierk Scheinert of Universitätsklinikum in Leipzig, Germany.

In the 300-patient Illumenate trial, the device beat out percutaneous transluminal angioplasty, with just more than 92% of the DCB-treated cohort meeting the safety endpoint, compared to 83.2% for the PTA-treated control group. The primary efficacy endpoint was reached for 82.3% of the Stellarex group, compared with 70.9% of the PTA-treated group.

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