Spectranetics to Acquire Covidien's Stellarex Drug-Coated Balloon Assets

November 2, 2014—Spectranetics Corporation and Covidien announced a definitive agreement under which Spectranetics will acquire Covidien's Stellarex drug-coated angioplasty balloon (DCB) platform for $30 million. The companies advised that the transaction is subject to approval by the Federal Trade Commission and other regulatory agencies, as well as closure of the pending acquisition of Covidien by Medtronic. The Medtronic–Covidien­ transaction is expected to occur in early 2015.

According to the announcement, European CE Mark approval for the Stellarex DCB platform is anticipated in late 2014 or early 2015. Spectranetics expects a European launch of the product immediately upon CE Mark approval. In the United States, the company will commercialize the device following US Food and Drug Administration approval, which is expected in the 2017 timeframe.

The Stellarex DCB platform, which is designed to treat peripheral arterial disease, uses EnduraCoat technology, a durable, uniform coating designed to prevent drug loss during transit and facilitate controlled, efficient drug delivery to the treatment site. The Stellarex DCB platform currently is not approved for sale in any market.

As stated in the announcement, data from the ILLUMENATE first-in-human (FIH) study was reported at the EuroPCR Scientific Congress in May 2014. The ILLUMENATE FIH study is a prospective, multicenter, single-arm study designed to assess the clinical performance of the Stellarex DCB.

In the study, 58 superficial femoral and/or popliteal lesions (up to 15 cm in length) in 50 patients were predilated with an uncoated angioplasty balloon, followed by treatment with the Stellarex DCB. Clinical events were adjudicated by independent angiographic and sonographic core laboratories. The study found the Stellarex DCB to be safe, with durable results to 24 months reported on 44 patients.

Specific findings from the ILLUMENATE FIH study included: primary patency (defined as the treated artery remaining open without further treatment required or renewed blockage detected by ultrasound scanning) was 89.5% at 12 months and 80.3% at 24 months; freedom from clinically driven target lesion revascularization at 24 months was 85.8%; and no amputations or cardiovascular deaths were reported.

The Stellarex DCB platform is being studied in five investigational device exemption trials in the United States and internationally that will be used to evaluate the safety and effectiveness of the Stellarex DCB platform and support United States and Canada regulatory approval. In addition to the ILLUMENATE FIH trial, there are four active ILLUMENATE clinical trials. The ILLUMENATE PK pharmacokinetic study, with 25 patients to be enrolled at up to two sites, is evaluating the drug levels in the blood. The ILLUMENATE pivotal randomized trial will enroll 360 patients at up to 45 sites to support the premarket approval application in the United States. The ILLUMENATE EU European randomized trial will enroll 360 patients at up to 30 sites. The ILLUMENATE global registry is a nonrandomized study that will enroll 500 patients at up to 65 sites, advised the companies.