Cardio

Acutus Medical has pioneered an innovative approach in the minimally invasive imaging and mapping of cardiac arrhythmias. Now the company has announced the gaining of CE Mark approval for its proprietary real-time 3D diagnostic imaging and dipole density mapping catheter.

Edwards Lifesciences has used the AATS Annual Meeting to trumpet three-year clinical outcomes of its EDWARDS INTUITY valve platform which demonstrated improved cardiac and valvular performance, as well as patient functional status compared with the standard valve equivalent.

Italian Cardiovascular company Sorin Group, has received U.S. FDA approval for the Mitroflow Aortic Pericardial Heart Valve with Phospholipid Reduction Treatment (PRT).

No doubt timed to coincide with the FDA’s Class I recall notice, HeartWare International, Inc. has itself issued a clinician and patient reminder concerning last December’s Urgent Medical Device Correction relating to its Ventricular Assist System.

Medtronic recently gained the FDA’s nod to commence its IDE study into Evera, and the device has now seen its first implant performed, as part of the Medtronic randomized, global pivotal clinical trial that will enroll up to 275 patients at approximately 45 centers.

Two of last week’s news items have moved on a bit over the Easter weekend: Medtronic’s increasingly acrimonious spat with Edwards over the respective companies’ transcatheter heart valve offerings, and Covidien’s recall being graded Class I by the FDA.

St. Jude is sounding punchy, expecting revenue gains based on a flurry of new product approvals.

Boston Scientific Corporation has received FDA approval for its latest generation of defibrillators and heart failure devices, including the DYNAGEN™ MINI and INOGEN™ MINI ICDs, as well as the DYNAGEN™ X4 and INOGEN™ X4 CRT-Ds.

PROCEED II heart transplant FDA pivotal trial results using the Organ Care System (OCS™) Heart platform have been presented at the International Society for Heart and Lung Transplantation (ISHLT) 34th Annual Meeting and Scientific Sessions in San Diego, California.

Late last week Edwards Lifesciences announced that the U.S. District Court for the District of Delaware had granted a preliminary injunction, limiting the sale of Medtronic’s CoreValve system in the United States. The court ordered the injunction to go into effect in seven business days.

Abbott has announced the completion of enrollment of three clinical trials to support approvals of the company’s revolutionary Absorb™ Bioresorbable Vascular Scaffold (BVS) in the United States, Japan and China.

Medtronic has gained CE Mark approval for its Evera MRI™ SureScan® implantable cardioverter-defibrillator (ICD) System. The company says this is the first and only ICD system approved for magnetic resonance imaging (MRI) scans positioned on any region of the body.

Abiomed has received CE Mark approval to market its Impella RP device in the European Union, providing a non surgical heart support option for patients with reduced right ventricular function.

Cardiac device company Mitralign Inc., has completed enrollment in a European study to investigate the performance of its simple, but clever system of cinched anchors in patients with functional mitral regurgitation (FMR).

A pooled analysis study of the Parachute, first-of-its-kind catheter-based treatment for heart failure has been presented at ACC 2014 and the results look encouraging, with left ventricular volume reduction and heart function improvement.

Medtronic has signalled its intent to get to the sharp end in a significant market, by acquiring a majority of the shares of Biostar, which will assume the distribution of Medtronic products in Turkey. Former distributor Medicall Biomedikal A.S. will assume management responsibilities.