Medtronic plc launched the newest product in its coronary portfolio, the Prevail drug-coated balloon (DCB) catheter, in Europe following CE mark approval. The device is intended for use during minimally invasive procedures to open narrowed or clogged arteries in patients with coronary artery disease.
Medtronic plc kicked off an app-based research study to improve understanding of atrial fibrillation (AF) disease burden and its impact on patient outcomes, quality of life and health care utilization. The first patients in the DEFINE AFib study were enrolled at Duke University Medical Center and the Florida Electrophysiology Associates in Atlantis, Fla. “When it comes to managing atrial fibrillation, there is not a ‘one-size-fits-all’ approach, and the hope is that DEFINE AFib may give us the tools to help personalize AF management based on a patient’s individual health profile and physiology,” said Jonathan Paul Piccini, director of cardiac electrophysiology and associate professor of medicine at Duke University School of Medicine and chair of the DEFINE AFib Steering Committee. “DEFINE AF will harness the power of digital health to make fundamental discoveries about how we can manage atrial fibrillation better in each and every one of our patients.”
Medtronic plc won expanded FDA 510(k) approval for its Arctic Front family of cardiac cryoablation catheters for alternative treatment of recurrent symptomatic paroxysmal atrial fibrillation (AF) as an alternative to the current standard first-line treatment, antiarrhythmic drug (AAD) therapy. The Arctic Front family of catheters are the first catheter ablation devices in the U.S. approved to help physicians improve AF patient outcomes before drug failure. They have also been proven to shorten the time to diagnosis, according to Dublin-based Medtronic.
TORONTO – Titan Medical Inc. has received a $10 million license payment from Medtronic plc for a total of $30 million that the Irish med-tech firm has invested in robotic-assisted surgical technologies developed by Titan. Titan is pursuing gynecologic surgical applications for its Enos robotic single access surgical system, licensing it and related intellectual property to Medtronic while retaining worldwide rights to commercialize technologies for use with the Enos system.
Medtronic plc snagged FDA premarket approval for its recharge-free implantable neurostimulator (INS), Vanta, for patients with intractable pain. The spinal cord stimulator offers up to 11 years of device life, with optimal programming. That represents a 10% improvement on the Dublin-based company’s previous longest-lasting INS, Primeadvanced, and a near doubling of device life compared to Abbott Laboratories’ Proclaim and Boston Scientific Corp.’s Wavewriter Alpha, using the settings recommended in the clinician manuals.
Medtronic plc is ceasing global sales and distribution of its Heartware ventricular assist device (HVAD) due to safety concerns. The news sent Medtronic shares down about 1% in early morning trading. The Dublin-based company said it made the decision to stop selling the HVAD left ventricular assist device after clinical comparisons found a higher frequency of neurological adverse events, including stroke and mortality, with its heart pump device vs. other circulatory support systems.
Percutaneously implanted devices designed to seal off the left atrial appendage (LAA) have been around for some time, but a recent study of surgical closure of the appendage might have a beneficial effect on sales of these devices despite that the study did not deal directly with these devices. The results were compelling enough to provoke a halt to the study before all patients had reached the projected term of follow-up, and at least one observer said it may be time to study whether more routine use of devices for percutaneous LAA closure is indicated.
Two-year results from the Evolut Low Risk Trial show Medtronic plc’s Evolut transcatheter aortic valve replacement (TAVR) is noninferior to open-heart surgery in younger, healthier aortic stenosis patients. Moreover, the Evolut cohort fared better on certain critical events. Specifically, two-year rates of all-cause mortality or disabling stroke were 4.3% for TAVR patients vs. 6.3% for those undergoing surgical aortic valve repair (SAVR).
Almost 11 years to the day after first gaining FDA clearance, the Sonarmed airway monitoring system finally launched on a commercial scale in the U.S. The new rollout appears likely to revive the product’s prospects as it comes with significantly increased financial backing and deep connections to hospitals as a result of Sonarmed’s acquisition by Medtronic plc in December 2020. The system, which uses acoustic technology to identify endotracheal tube obstruction and verify proper tube positioning in neonates and infants who require invasive mechanical ventilation, has been implemented in a small number of hospitals to date.
Medtronic plc has launched Careguidepro, its first patient-focused digital tool for spinal cord stimulation. The mobile app and online portal enables providers to better manage patients’ pain relief with real-time feedback and data.
