Spectranetics and Covidien have announced a definitive agreement under which Spectranetics will acquire Covidien’s Stellarex drug coated angioplasty balloon platform for US$30 million.
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, which is expected to occur in early 2015.
It is anticipated that the Stellarex drug coated angioplasty balloon platform will receive European CE mark approval in late 2014 or early 2015. Spectranetics expects a European launch of the product immediately upon CE mark approval, with US commercialisation in the 2017 timeframe, following FDA approval, a press release from Spectranetics states.
“This acquisition advances Spectranetics’ objective to provide comprehensive solutions to cross, prepare and treat the most complex vascular conditions,” said Scott Drake, president and CEO, Spectranetics. “Drug coated balloons are and will be an integral part of the vascular landscape for many years to come. Global thought leaders believe that primary patency is the most important clinical metric, and Stellarex’s feasibility data stands apart. We believe this technology will meaningfully add to our near-term revenue growth and expand operating leverage over time.”
“The Stellarex team has made significant progress developing this advanced technology and we are confident that Spectranetics is the right organisation to advance the programme,” said Brian Verrier, president, Peripheral Vascular, Covidien. “Pending completion of the Medtronic transaction, Covidien looks forward to collaborating with Spectranetics to transfer this technology as well as ensure investigators of the ILLUMENATE trial series are transitioned appropriately.”
The Stellarex drug coated balloon platform is designed to treat peripheral arterial disease. Stellarex 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 platform currently is not approved for sale in any market.
About ILLUMENATE first-in-human study
Data from the ILLUMENATE first-in-human study was reported at the EuroPCR Scientific Congress in May 2014. The study is a prospective, multicentre, single-arm study designed to assess the clinical performance of the Stellarex drug coated balloon. In the study, 58 superficial femoral and/or popliteal lesions (up to 15 cm in length) in 50 patients were pre-dilated 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 drug coated balloon to be safe, with durable results to 24 months reported on 44 patients, including:
- 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 revascularisation at 24 months was 85.8%
- No amputations or cardiovascular deaths were reported.