Sorin Group (BIT:SRN) said it won CE Mark approval in the European Union for its Solo Smart heart valve, designed to replace the aortic valve without leaving a stent in place.
CE Mark
Boston Scientific wins CE Mark, FDA nod for Direxion microcatheter
Boston Scientific (NYSE:BSX) said its Direxion microcatheter notched regulatory wins in the U.S. and Europe for peripheral embolization.
Boston Scientific adds dystonia indication to CE Mark for Vercise DBS device
Boston Scientific (NYSE:BSX) said it won CE Mark approval in the European Union for its Vercise deep-brain stimulation device for treating the movement disorder called dystonia.
Boston Scientific’s TAVI system hits the German market
Boston Scientific (NYSE:BSX) has officially hit the German market with the 1st commercial patients treated this month, just weeks after the company won CE Mark approval to sell the product in the European Union.
ReliantHeart expands CE Mark for HeartAssist5 ventricular assist device
ReliantHeart this week won expanded CE Mark approval in Europe for its ventricular assist device, which the company calls "the only remotely monitored VAD in the world."
The HeartAssist5 system originally won European approval under MicroMed Technology Inc. and was available commercially in 2009, according to a press release. ReliantHeart won the MicroMed’s assets through "the completion of a court approved transaction," the company said.
Avedro wins CE Mark for its KXL II system
Waltham,Mass.-based Avedro said it won CE Mark clearance in the European Union for its KXL II cross-linking system.
The technology uses a photorefractive intrastromal cross-linking procedure for non-surgical correction of myopia as well to improve cataract surgery outcomes, according to a company statement.
Germany’s BioCer lands E.U. win for mastectomy bra, U.S. win for hernia mesh
German medical device maker BioCer this week touted regulatory wins in the U.S. and in the U.K. for devices in its TiO2Mesh line, including for its mastectomy bra and hernia repair mesh.
Topera lands CE Mark, 510(k) clearance for heart catheter
Topera said it landed a pair of regulatory wins for its FIRMap catheter.
The Palo Alto, Calif.-based medical device company said it won the CE Mark approval in the European Union and 510(k) clearance from the FDA for the device.
Gore wins CE Mark for iliac branch Excluder stent graft
W.L. Gore & Assoc. said it won CE Mark approval in the European Union for its Excluder iliac branch stent graft.
Gore said the device is designed to isolate the common iliac artery from systemic blood flow, preserving flow in the external and internal iliac arteries, when used with Excluder AAA endoprosthesis.
Biotronik wins CE Mark for PK Papyrus coronary stent
Biotronik announced today that it won CE Mark approval in the European Union for its PK Papyrus coronary stent system.
The Papyrus device is approved for treating acute coronary artery perforation, and features an innovative “electrospun” membrane to increase flexibility by 58% over its competitors, according to a Biotronik company statement.
Reverse Medical lands CE Mark, 510(k) for brain catheters
Reverse Medical Corp. said it won CE Mark approval in the European Union and 510(k) clearance from the FDA for its ReVerse neurovascular microcatheter device.
The regulatory nods are for use in the neurological, peripheral and coronary vasculature for the infusion of diagnostic and therapeutic agents, according to a press release.