Cardio

Medtronic and Edwards Lifesciences have buried the hatchet in their ongoing patent disputes with the former coughing up an immediate $750 million plus future amounts based on sales.

We’ve followed Direct Flow Medical’s twin-inflatable ring TAVI offering as it gained CE mark approval in Europe. Now it’s reached the next phase in the U.S as it gains FDA’s nod to commence the pivotal phase of its IDE trial.

STENTYS, with its clever world-first (and indeed only) Self-Apposing® Stent to treat acute myocardial infarction (AMI), has seen final results from the APPOSITION IV study of its new Self-Apposing sirolimus-eluting stent (SES) presented during the Hotline session at the EuroPCR conference in Paris.

Juventas JVS-100 Gene Therapy delivered to heart muscle using the Biocardia Helix system, has been delivering promising clinical data, as presented at the European Society of Cardiology Heart Failure Congress in Greece.

It’s six months since we heard from Miracor Medical Systems about progress with its PICSO® (Pressure-controlled Intermittent Coronary Sinus Occlusion) System. Now the company has announced that clinical study data will be presented from the podium at “EuroPCR.”

The big news in transcatheter aortic valve development is that St. Jude Medical, Inc. has seen the first patient implants in the Portico™ Re-sheathable Transcatheter Aortic Valve System U.S. IDE Trial (PORTICO trial). The trial is evaluating the Portico™ Transcatheter Aortic Valve System, claimed by St. Jude to be the first aortic heart valve that is repositionable until fully deployed.

The U.S. FDA has deemed as a Class 1 recall the Datascope Corporation/MAQUET voluntary worldwide field correction, issued in March of certain of the company’s Intra-Aortic Balloon Pumps (IABPs). A potential mechanical failure means the system could shut down, with adverse patient consequences.

In a new study, St.Jude’s Quadripolar left ventricular pacing system demonstrated 53% reduction in hospitalization translating into 62% overall cost reduction compared with its non-Quadripolar system.

Biotronik says the U.S. FDA has approved its Entovis pacemaker system with ProMRI® technology. The Entovis system allows patients to undergo MRI scans with a limited exclusion zone. FDA approval covers both single chamber (SR-T) and dual chamber (DR-T) Entovis pacemakers when implanted with Setrox pacing leads.

One of three judges has departed the room. Then his replacement votes against his view. Then someone who voted against him last time, changes her mind. Not like this is important or anything.

A new, randomized study, supported by Boston Scientific, presented at this year’s HRS event suggests that ICD patients do equally well, regardless of whether their implant was defib tested at the time of implantation.

The first patient has been treated in the RECARDIO clinical trial studying the safety and preliminary efficacy of endocavitary intramyocardial injection of autologous bone marrow-derived CD133+ cells as delivered by BioCardia’s Helix™ Transendocardial Delivery System in patients with ischemic refractory cardiomyopathy.

St. Jude Medical, Inc., has announced results of the TOCCASTAR clinical trial, the first prospective, randomized study of contact-force ablation technology for the treatment of paroxysmal atrial fibrillation (AF). The trial met its primary endpoints and supplements the growing body of evidence that supports the safety and effectiveness of contact-force ablation technology.

Medtronic, Inc. has gained CE Mark approval and will now launch its newest cardiac resynchronization therapy-pacemaker, Viva® CRT-P in Europe.

Thoratec Corporation has reported its financial results for the first quarter of 2014. International sales of the Heartmate device continue to dominate the revenue line, with 7% growth compared with the equivalent quarter a year ago.

HeartWare International has issued another warning to its customers. This time its a voluntary Urgent Medical Device Correction related to all HeartWare® Ventricular Assist System batteries, product codes 1650 and 1650-DE.