Medtronic today announced that it received National Medical Products Administration approval in China for its CoreValve Evolut Pro TAVR system. The approval marks the first Medtronic TAVR system approved in China for patients with symptomatic severe aortic stenosis who are at high or extreme risk for open-heart surgery, according to the … [Read more...] about Medtronic Evolut Pro TAVR wins approval in China
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Medtronic to acquire cardiac arrhythmia treatment developer Affera
Medtronic (NYSE:MDT) announced today that it agreed to acquire cardiac mapping and ablation technology developer Affera. Newton, Massachusetts-based Affera designs and manufactures cardiac mapping and navigation systems, as well as catheter-based cardiac ablation technologies, including a differentiated, focal pulsed-field ablation platform for … [Read more...] about Medtronic to acquire cardiac arrhythmia treatment developer Affera
Medtronic says study results show alternative spine procedures could reduce opioid use
Medtronic (NYSE: MDT) says a study shows its balloon kyphoplasty (BKP) and vertebroplasty (VP) technology could eliminate opioid use among many with spinal fractures. The medical device giant sponsored a retrospective claims analysis of a large, nationally representative insurance claims database. The results — recently published in Osteoporosis … [Read more...] about Medtronic says study results show alternative spine procedures could reduce opioid use
What is renal denervation? Medtronic Coronary and RDN President Jason Weidman explains
Medtronic (NYSE:MDT) continues clinical trials of its Symplicity Spyral renal denervation (RDN) system for treating hypertension. The hope now is to win FDA approval in 2023. To better understand the technology behind what Medtronic leaders expect to become a multibillion-dollar business, Medical Design & Outsourcing spoke with Jason … [Read more...] about What is renal denervation? Medtronic Coronary and RDN President Jason Weidman explains
Medtronic touts 5-year study of self-expanding TAVR platform
Medtronic (NYSE:MDT) today presented five-year clinical data for its CoreValve and Evolut transcatheter aortic valve implantation (TAVI) platforms. Fridley, Minnesota-based Medtronic presented results from the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial at the 33rd Transcatheter Cardiovascular Therapeutics … [Read more...] about Medtronic touts 5-year study of self-expanding TAVR platform
Medtronic issues warning for some perfusion tubing packs
Medtronic has issued a warning letter regarding some of its Perfusion Tubing Packs. Friedly, Minnesota-based Medtronic's urgent field safety notice informs users that some of its Perfusion Tubing Packs were manufactured without device-level testing for bacterial endotoxin, which is a necessary step to support non-pyrogenic label claim. The … [Read more...] about Medtronic issues warning for some perfusion tubing packs
Medtronic faces longer road to renal denervation
Medtronic (NYSE:MDT) will continue the clinical study of its Symplicity Spyral renal denervation (RDN) system for hypertension into next year after lacking the positive results needed to end enrollment early. Fridley, Minnesota-based Medtronic said last month that it hoped to present results of the Spyral HTN-ON MED trial at the Cardiovascular … [Read more...] about Medtronic faces longer road to renal denervation
Medtronic wins CE mark approval for radial artery access portfolio
Medtronic today said it has received CE mark approval for its radial artery access portfolio. The radial artery access devices include the Rist 079 radial access guide catheter and the Rist radial access selective catheter. Medtronic designed the Rist 079 guide catheter to access the neuro vasculature through the radial artery instead of … [Read more...] about Medtronic wins CE mark approval for radial artery access portfolio
Medtronic’s Pipeline Flex problems expand
The FDA today issued a notice confirming a Class I recall of the Pipeline Flex embolization device from Medtronic (NYSE:MDT). Several models of the Pipeline Flex embolization device and Pipeline Flex embolization device with Shield Technology were affected, with 8,825 devices recalled in the U.S., having been distributed between April 18, 2019, … [Read more...] about Medtronic’s Pipeline Flex problems expand
Medtronic releases Navablate study results for bronchoscopic microwave ablation
Medtronic (NYSE:MDT) reported new clinical data from its Navablate study of bronchoscopic microwave ablation with its Emprint ablation catheter kit to treat malignant lung nodules. “Patients with malignant lesions in the lung often have limited therapy options due to lesion locations, comorbidities and treatment side effects,” said one of the … [Read more...] about Medtronic releases Navablate study results for bronchoscopic microwave ablation