US-based Spectranetics (SPNC) has entered into an agreement with Irish healthcare firm Covidien to acquire its Stellarex drug coated angioplasty balloon (DCB) platform, for $30m.
The deal is subject to approval by the Federal Trade Commission and other regulatory agencies, as well as completion of the pending acquisition of Covidien by Medtronic, which is scheduled to take place in early 2015.
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Spectranetics CEO Scott Drake said: "This acquisition advances SPNC’s objective to provide comprehensive solutions to cross, prepare and treat the most complex vascular conditions.
"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."
The company said that the Stellarex DCB platform is expected to receive European CE Mark approval later this year, or in early 2015.
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By GlobalDataSpectranetics will launch the product immediately in Europe upon the receipt of CE Mark approval, but plans to commercialise the device in the US in 2017, following approval from US Food and Drug Administration (FDA).
Covidien Peripheral Vascular president Brian Verrier said: "The Stellarex team made significant progress developing this advanced technology and we are confident that Spectranetics is the right organisation to advance the programme.
"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."
Stellarex DCB platform is designed to treat peripheral arterial disease, using EnduraCoat technology, a durable, uniform coating designed to prevent drug loss during transit and facilitate controlled, efficient drug delivery to the treatment site.
The prospective, multi-centre, single-arm ILLUMENATE FIH trial is designed to evaluate the clinical performance of the Stellarex DCB.
In the trial, 58 superficial femoral and/or popliteal lesions in 50 patients were pre-dilated with an uncoated angioplasty balloon, followed by treatment with the Stellarex DCB.
