It’s interesting to see Edwards Lifesciences reporting a sales increase of over eight percent compared with a year ago (10% on constant currency basis), yet still sounding disappointed that it missed its projections. Looking forward it’s watered things down a bit too.
Cardio
InspireMD Gets FDA Nod To Begin US Regulatory Trial Of MGuard™ Stent
InspireMD, Inc., the developer of the MGuard™ Embolic Protection Stent (EPS), has announced approval with conditions for its US FDA Investigational Device Exemption (IDE) application. This approval allows the company to initiate enrollment in the MASTER II IDE trial.
Right Ventricle Assessment Tool CE Mark Extended To More Heart Patients
Ventripoint’s right ventricle ultrasound assessment tool was hitherto only CE marked for use in patients with right ventricle-associated disease. Now it can be used in a wider patient cohort, so picking up patients with concomitant heart disease.
First Implantation Of TYRX® AIGISRx® R Fully Resorbable Antibacterial Envelope
TYRX, Inc., a company focused on the commercialization of implantable medical devices intended to help reduce surgical site infections, has seen the first implantation of its new AIGISRx® Fully Resorbable Antibacterial Envelope take place in Canada.
CE Mark For Thoracic-Length Heli-FX Aortic Aneurysm Graft System
Aptus Endosystems has gained CE mark approval for the thoracic version of its Heli-FX™ endovascular aneurysm repair graft. The the new system consists of a longer delivery device with additional tip configurations to bring the innovative helical EndoAnchor™ technology to the treatment of thoracic aortic aneurysms.
Mitral Valve Patients Urged To “Hold On” Until MitraClip Gets The Nod
We’ve opined before about the weird regulatory divide that sees life-saving technologies withheld from U.S. patients while being freely available in Europe. It seems the clinical community shares the view,as one physician/author shows her frustration at the continued unavailability of Abbott’s MitraClip.
Argon Medical Launches OptionELITE Retrievable Vena Cava Filter
Argon Medical has announced the launch of a new Vena Cava filter. It claims the OptionELITE’s enhanced retention anchor pattern provides stability and reduced retrieval force while preventing migration and reducing the risk of penetration.
TAVI Results At German Cardio Society Meeting
At last week’s Annual German Cardiac Society meeting Swiss transcatheter valve developer Symetis saw registry data from the Symetis ACURATE TA™ Valve Implantation (SAVI) Registry presented. Low leakage and mortality reported.
Resorbable, Drug-Eluting Stent Study Initiates Enrollment
Really clever “slide and lock” mechanism features in the design of this bioresorbable drug eluting coronary stent. Reva Medical has now commenced enrollment in the study it hopes will get it to regulatory approval in Europe.
FDA Clears Medtronic’s New Affinity Fusion Oxygenation System For Adult Cardiac Surgery
Medtronic, Inc. has gained U.S. FDA 510(k) clearance of its new Affinity Fusion® oxygenation system. The system is designed to serve as a patient’s lungs by oxygenating and removing carbon dioxide from blood during various open-heart surgical procedures.
First Patient In Abiomed’s Impella RP IDE Study
Abiomed gets the ball rolling with news that it has seen a first patient implated with its Impella RP in the U.S. IDE study into the device. Abiomed is seeking FDA approval under Humanitarian Device Exemption rules.
First German Patient Treated Post PCI With PICSO® System Following Severe Heart Attack
Miracor Medical Systems GmbH has been trumpeting the first German patient to be successfully treated using its PICSO® (Pressure-controlled Intermittent Coronary Sinus Occlusion) System. PICSO is designed to improve myocardial perfusion following primary PCI (Percutaneous Coronary Intervention, or angioplasty).
Biotronik Celebrates 50th Birthday With Iforia CE Mark, World’s First MRI-Approved DF4 ICD/CRT-D
Cardiac device and remote monitoring specialist company Biotronik is 50 years old. The company is having a double celebration as it is also announcing the CE mark approval of its MRI compatible Iforia ICD/CRT-D implant
Percutaneous CV Device Co Gains Chinese Distribution Deal
CV device company TriReme has announced the signing of a comprehensive agreement with Weihai Weigao Medical Devices, Ltd for the distribution of its products in the People’s Republic of China. Weigao will act as TriReme’s master distributor by selling TriReme products directly to hospitals as well as connecting TriReme products into its vast nationwide distribution network.
Catheter Ablation AF Treatment Study Yields Contact Force Guidelines
Contact-force reportedly has a bearing on the efficacy and safety of catheter ablation for the treatment of cardiac arrhythmias. Now sensing technology company Endosense has seen the results of its EFFICAS I prospective multi-center study published in the April 2013 issue of the American Heart Association journal Circulation: Arrhythmia and Electrophysiology.
FDA Approves AdReview™ Mortality Risk Indicator
Heart failure is associated with increased myocardial sympathetic nerve activity, which in turn depletes local capacity for norepinephrine uptake and storage. AdreView measures that capacity, so provides an indication of heart disease status.