Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for a 6 French version of its HawkOne directional atherectomy device designed for treating peripheral artery disease.
The Fridley, Minn.-based company’s device is designed as a treatment for PAD which can operate both above and below the knee.
“Directional atherectomy is an established treatment modality for patients with complex PAD to restore patency, maximize luminal gain and preserve future treatment options. The new smaller HawkOne 6F size is an advanced option to treat patients with multi-level PAD, addressing lesions of various length, morphology, and location, particularly those below the knee,” Dr. Thomas Zeller of Bad Krozingen, Germany’s Universitäts-Herzzentrum Freiburg said in prepared remarks.
Medtronic touted improvements in the HawkOne system, saying it can treat calcified lesions up to 2 times more effectively than the TurboHawk device. The system comes with a preloaded flush tool, which the company claims can reduce cleaning time by up to 55% compared with the TurboHawk.
“We are excited to announce CE Mark approval for HawkOne 6F shortly after receiving FDA clearance for the system in October. The HawkOne 6F system provides physicians with an effective and efficient treatment option for treating PAD above and below the knee and reinforces our commitment to expand access to therapy innovations that protect limbs and enhance lives,” peripheral biz GM & VP Mark Pacyna said in a press release.
Earlier this month, Medtronic said it won CE Mark approval in the European Union for a 34 mm size of its CoreValve Evolut R replacement heart valve in intermediate-, high- or extreme-risk patients.
Medtronic said the approval opens the CoreValve Evolut R transcatheter aortic valve replacement as an option for some 20% to 25% of patients with diseased aortic valves. The the valve originally won CE Mark approval in September 2014; the FDA approved the device in July 2015 and gave the 34 mm size a nod last October.