Boston Scientific failed to meet the primary endpoint of reduced stroke in the PROTECTED TAVR study. The company presented the results of the study, which evaluated the Sentinel Cerebral Protection system, last weekend at the Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium in Boston. The device was designed to capture and remove embolic debris stemming from transcatheter aortic valve replacement before it can reach the brain and potentially cause a stroke.
Medtronic issued an urgent medical device correction warning of a MiniMed 600 Series insulin pump system communication issue uncovered by the company. Medtronic reported in its September 20 letter that these insulin pump systems are vulnerable to cyberattacks and hackers could potentially hamper insulin delivery by accessing the device, administering too much or too little insulin to the devices recipient.
And in case you missed our last Medtech in a Minute report...
Second Sight Medical Products as the company has completed its merger with Nano Precision Medical and rebranded as Vivani Medical. The retinal prosthesis company was part of a failed merger with Pixium Vision last year.
A year after pulling its HeartWare Ventricular Assist Device (HVAD) System from the market, Medtronic is still dealing with regulatory issues associated with the device. The latest Medtronic recall relates to an increase in battery electrical faults due to an interaction between the HeartWare battery software and an internal component. This is the third recall associated with the HVAD System since the company discontinued it last year.
A new collaboration between Medtronic and BioIntelliSense, as well as Masimo's W1 launch, added some spice to the wearables space this week. Medtronic has agreed to distribute BioIntelliSense’s BioButton multi-parameter wearable designed for continuous, connected monitoring. Masimo announced a full market release of its W1 wrist-worn wearable for consumer use, and entered into a general launch phase for a medical version of the watch outside the United States. The medical version of Masimo W1 includes additional measurement capabilities including pot-check electrocardiogram (ECG), and atrial fibrillation (A-fib) detection.