Cardio

Israeli heart monitoring company, Aerotel Medical Systems has received the CE Mark approval for its new ECG devices, HeartView P12/8i and HeartView 12L.

Abiomed has issued a press release announcing the completion of the target of 30 patients enrolled in RECOVER RIGHT, an Investigational Device Exemption (IDE) study of Impella® RP.

German device company Transcatheter Technologies GmbH, has announced the successful 6-month follow-up results for a pilot study of its Trinity TAVI system that is designed to be the world’s first ‘truly repositionable’ and, therefore, best (so says the company’s press release) TAVI system.

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, today announced FDA clearance of its proprietary instant wave-Free Ratio™ or iFR® Modality.

St. Jude Medical’s large European clinical trial of its Nanostim pacemaker is hoped to add to the building evidence supporting strong safety profile and performance of the world’s first leadless pacemaker.

French artificial heart developer Carmat has its fate in the hands of four patients, one of whom has already died and three of whom are yet to be implanted. While that sounds like a perilous position to be in, these patients are already very sick and if they survive a month the study will be considered a success.

Thoratec has issued updated information regarding the problems highlighted in its device correction letter of two weeks ago. It’s reinforcing the guidance that patients should visit their doctor for retraining on how to use the Heartmate II device in the light of new evidence that the process of changing from older controllers presents the highest risk of problems.

We’ve no idea whether wrapping a nitinol mesh around a vein graft to protect it against damage and undue stresses addresses a real problem or not, but it seems like a sensible concept. The company has gained FDA’s approval to increase its study size.

BioCardia®, Inc. has gained CE Mark approval for its Morph AccessPro™ Steerable Introducer, designed for easier navigation through the vasculature during delivery of biotherapeutics and medical devices.

The U.S. FDA has said Biotronik can move onto phase C of its ProMRI study which will investigate the company’s MRI-compatible technology in its implantable cardioverter-defibrillator (ICD) devices.

Italian Cardiovascular device company Sorin Group has announced the purchase of the Oscor Inc. lead business, including a lead manufacturing facility in the Dominican Republic for an aggregate value of approximately $20 million (Eur15.4 million).

Boston Scientific Corporation has announced CE Mark approval and European market launch of the INGEVITY™ family of magnetic resonance imaging (MRI) compatible pacing leads.

Boston Scientific Corporation has received CE Mark approval for the REBEL™ Platinum Chromium Coronary Stent System, the company’s latest generation … continue reading “CE Mark for Boston Scientific’s REBEL™ Platinum Chromium Coronary Stent”

When it gains approval the Smaller 50cc SynCardia Heart and new Permanent Use indication will triple the number of heart failure patients who can get a 2nd chance at life, says the company.

Ventripoint Diagnostics Ltd. has announced that the U.S. FDA has cleared the VMS™ heart analysis system to be an adjunct to all existing 2D ultrasound imaging devices to allow computation of the 3D volume and ejection fraction of the right heart in patients with Pulmonary Arterial Hypertension

Edwards Lifesciences Corporation has announced the successful completion of the first three human implants of its FORTIS mitral transcatheter heart valve, which were performed in February and March by the Heart Team at St. Thomas’ Hospital in London.