Regulatory

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.

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.

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

It’s Digestive Disease (DDW) 2014 this week in Chicago, IL. and Olympus has chosen the event at which to launch its newly cleared “next-generation” ENDOCAPSULE 10 System for small bowel capsule endoscopy procedures.

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.

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.

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

GS Medical USA, LLC, tells us that its AnyPlus® T/PLIF Cage has received U.S. FDA 510(k) clearance. The new system expands the Company’s successful AnyPlus® platform of cages and will now see its U.S. launch.

CrossBay Medical, Inc., has announced a bevvy of regulatory clearances. The company’s SonoSure™ Sonohysterography and Endometrial Sampling Device now has U.S.FDA and Health Canada clearance as well as CE mark approval.

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.

Robotic surgery specialist, Intuitive Surgical, Inc, says it has received U.S. FDA 510(k) clearance for the da Vinci Sp Surgical System, which is designed to expand the Company’s single-incision product offering. This initial clearance is specific to urologic surgical procedures that are appropriate for a single port approach.

The EndoStim LES Stimulation System has received CE Mark approval for use with Magnetic Resonance Imaging (MRI), and is now conditionally approved for MRI scans of head and extremities.

Cochlear Limited, the global leader in implantable hearing solutions, has announced that the U.S. FDA has approved the Aqua+ accessory, the only waterproof behind-the-ear solution for cochlear implant recipients on the market today.

The CE marking of Aperion Biologics, Inc.’s lead product, the Z-Lig™ device makes it the first engineered biological device to gain approval for revision and multiligament ACL reconstruction.

Breathe Technologies, Inc. has announced the U.S. FDA 510(k) clearance of its Non-Invasive Open Ventilation (NIOV) System, opening up the potential for it to be used with a compressed air supply for non-oxygen dependent patients.

ZipLine Medical says its Zip® Non-invasive surgical skin closure device is faster than sutures, can produce superior cosmesis compared to staples and reduce the risk of surgical site infection.