CE Mark Approval

CardioKinetix’s Parachute ventricular partitioning device has had its CE mark extended to include a full range of sizes, opening up percutaneous ventricular restoration therapy to a wider range of patient anatomies.

Volcano Corporation a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, said today it has received clearance to market its new Visions® PV .035 Digital IVUS Catheter in both the US and Europe. The new intravascular ultrasound catheter is designed to image large vessels and facilitate the use of less iodinated contrast in endovascular procedures.

Covidien has announced U.S. FDA 510(k) clearance and CE Mark approval for its next generation of Nellcor™ Bedside Respiratory Patient Monitoring system.

Medtronic announces CE mark for CoreValve® Evolut™, incorporating features designed for optimal fit. With the new 23mm iteration, Medtronic claims its CoreValve family treats the broadest range of patient valve sizes.

Medtronic, Inc. has announced CE Mark for its new Affinity Fusion® oxygenation system, opening the door to a European launch. The system, which oxygenates and removing carbon dioxide from blood during various open-heart surgical procedures, incorporates numerous innovations for claimed patient safety and ease of use.

St. Jude Medical, Inc. has announced it has received European CE Mark approval of its Eon™ family of neurostimulators for patients with intractable chronic migraine. The range includes the Eon Mini, which St.Jude says is the world’s smallest rechargeable neurostimulator with the longest-lasting battery in its class.

Sorin has announced CE Mark approval for extended indications of the Perceval™ S sutureless valve, expanding the market and, the company says, paving the way for adoption of Minimally Invasive Cardiac Surgery

Californian vascular device company Endologix, Inc., has gained CE Mark approval of the current version of its unique Nellix® EndoVascular Aneurysm Sealing System which involves filling the aneurysm sac with a bag full of a biostable polymer in patients with abdominal aortic aneurysms.

Sinus health company SinuSys Corporation, has announced that it has received CE Mark for its AerOs™ Sinus Dilation System. AerOs is designed to gently open the sinus ostia, thereby restoring natural sinus drainage and ventilation using a simple, two-step interventional approach.

NeuroSigma, Inc., a Los Angeles-based medical device company, announced today that it received CE Certification for its external Trigeminal Nerve Stimulation (eTNS™) system, called the Monarch™, for the adjunctive treatment of epilepsy and major depressive disorder, for adults and children 9 years and older. NeuroSigma’s approval was supported by years of safety and compelling efficacy data generated in clinical trials conducted at the University of California, Los Angeles (UCLA) and the University of Southern California (USC).

US/German device company CircuLite®, Inc. has announced that it has received CE Marking approval for the Synergy® Circulatory Support System, claimed by the company to be the world’s smallest surgically implanted blood pump designed for long-term use in patients diagnosed with the condition.

Konan Medical USA, Inc. has announced that its RAPDx® pupillograph for screening of defects in pupil function has received the European CE Mark. The company says its device breaks new ground, representing a diagnostic step change from the old “swinging flashlight” test.

German Neurovascular device company Acandis, has announced the CE mark approval of its novel Acclino® 1.9F low profile stent system, designed for use in the interventional neurovascular field as an adjunctive product in treating intracranial aneurysms with coils.

Boston Scientific’s Precisiopn Plus Spinal Cord Stimulator is now CE marked for peripheral nerve stimulation and implantees can receive MRI head-only scans, opening up diagnostic options for clinicians in Europe.

Elixir Medical claims to be the first company to now offer both durable and biodegradable polymer platforms for DES with the news that its absorbable polymer/drug eluting technology has been CE marked in the form of its DESyne BD Novolimus eluting stent system.

Boston Scientific’s Watchman LAA closure device can now be used on patients not able to be given anticoagulant therapy. Also, newly revised European Society of Cardiology guidelines include LAA closure devices.