The medical device industry has been working on miniaturizing pacemakers so they can be minimally invasively inserted and cause fewer difficulties for patients. Up next likely are closed-loop systems: pacemakers that record patient data, transmit that data externally and enable adjustment based on that data by physicians or even, eventually, on their own as guided by advanced algorithms.
Venus Medtech aims to have the first transcatheter aortic valve implantation system cleared by the China Food and Drug Administration (CFDA). It also has a transcatheter pulmonic valve that is finishing clinical trials, which would also be a first for the CFDA.
St. Jude Medical has launched its Axium Neurostimulator System for dorsal root ganglion stimulation to treat patients with chronic pain.
Medtronic has won the first U.S. approval for a leadless pacemaker from the FDA. The inch-long device is the smallest available and is implanted directly into the heart's right ventricle chamber. Traditional pacemakers require wired leads to connect the device to the heart.
St. Jude Medical touted an independent study from a New York healthcare system during the annual meeting of the American College of Cardiology, which showed patients who were implanted with the company's CardioMEMS patient monitoring cardiology implant experienced a plethora of benefits.
Medicare administrative contractor Novitas said it would not cover St. Jude Medical's implantable CardioMEMS heart failure monitor, dealing the device another reimbursement setback. Last, year First Coast Medicare denied coverage of the device in Florida, Puerto Rico and the Virgin Islands.
Leadless pacemakers from Medtronic and St. Jude Medical performed well in clinical trials, setting the stage for an exciting race for FDA approval between the two bigwigs. In a sign that the finish line is getting closer, the FDA is convening the experts on its circulatory system devices advisory panel to discuss optimal regulation of the devices.
St. Jude Medical has launched a portable version in Europe and Japan of its system to offer physicians a view from within the heart to enable physicians to make decisions during catheter-based stenting procedures. Dubbed Optis Mobile, the system is expected to offer comparable imaging as compared to the company's already marketed Optis Integrated System.
Last year St. Jude Medical agreed to pay $14.25 million to settle 950 pending legal claims related to its riata defibrillator leads. So news of a Class 1 recall of 447 Optisure defibrillator leads due to a manufacturing defect that may have introduced damage to the wires' insulation is rather unsettling.
St. Jude Medical needs to get its cardiac rhythm management unit back on track by filling gaps in the portfolio, CEO Michael Rousseau said at the J.P. Morgan Healthcare Conference in San Francisco.