Medtronic plc - MDT STOCK NEWS

Medtronic plc (NYSE:MDT) announced the U.S. launch of the SonarMed™ airway monitoring system, the first device to utilize acoustic technology for real-time monitoring of endotracheal tube position and obstruction in neonates. Each year, 415,000 infants require mechanical ventilation, with 75,000 suffering unplanned extubations. The SonarMed system aims to reduce these events, improving patient outcomes and lowering healthcare costs. Clinicians report significant improvements in care efficiency and reduced need for x-rays. The system is FDA-cleared and comprised of a bedside monitor and a single-use sensor.

Medtronic has launched CareGuidePro, a mobile app and web portal designed to assist patients undergoing spinal cord stimulation therapy. This platform allows patients to log pain relief and provide feedback, which helps care teams manage treatments more effectively. The app includes features such as caregiver access, procedure-specific FAQs, and secure communication among care teams. A limited commercial release is underway, with a wider release expected later in summer 2021. Medtronic emphasizes that digital health solutions will enhance patient engagement and outcomes.

Medtronic (NYSE: MDT) has announced the CE Mark approval of the Evolut™ PRO+ TAVI System, expanding its TAVI platform for treating symptomatic severe aortic stenosis. The system offers four valve sizes and features an external tissue wrap for enhanced sealing. This new approval supports treatment for low-risk surgical patients and those with bicuspid aortic valves. The Evolut PRO+ aims to improve hemodynamic performance while minimizing vascular access challenges, ultimately broadening patient eligibility for transfemoral procedures.

Medtronic plc (NYSE:MDT) announced promising interim results from the OPTIMIZE PRO clinical study involving 171 patients treated with the Evolut™ PRO and PRO+ TAVR systems for severe aortic stenosis. Key findings revealed zero deaths or disabling strokes and a low pacemaker rate of 8.8% at 30 days. The study highlighted excellent hemodynamic performance, with most patients experiencing expedited discharges within a median of one day. Conducted at multiple sites in the U.S., Canada, and Europe, the study aims to refine TAVR care pathways to enhance patient outcomes.

Medtronic plc (NYSE:MDT) has received Breakthrough Device Designation from the FDA for its Emprint™ ablation catheter kit, aimed at the minimally invasive treatment of lung malignancies. This investigational device, which works with the Emprint™ microwave generator and lung navigation platform, provides localized treatment while preserving lung function. Although not yet approved in the U.S., the device is CE Marked and has completed enrollment for the NAVABLATE study in Europe and Hong Kong. The FDA's designation will facilitate priority review and support in clinical trial designs for Medtronic.

Medtronic plc (NYSE:MDT) has received FDA approval for a clinical trial evaluating its implantable tibial neuromodulation (TNM) device designed to alleviate bladder incontinence symptoms. The TITAN 1 Feasibility Study will involve 20 participants across eight U.S. sites, with enrollment starting in May 2021. Over 37 million adults in the U.S. suffer from overactive bladder, but only 5% receive advanced therapy. Medtronic aims to provide more treatment options for these patients, building on its established sacral neuromodulation therapies, to address diverse patient needs.

Medtronic (NYSE:MDT) has partnered with Surgical Theater to integrate the SyncAR™ augmented reality (AR) technology with its StealthStation™ S8 surgical navigation system. This collaboration aims to enhance visualization for neurosurgeons during complex cranial procedures. By utilizing fighter-jet simulation technology, surgeons can access real-time patient-specific information and see a 360° AR rendering overlaid on live images during surgeries. This innovation promises improved precision and efficiency in treating brain tumors and aneurysms, offering significant benefits for patient outcomes.

Medtronic has received FDA approval for its Pipeline™ Flex Embolization Device with Shield Technology, designed to enhance flow diversion therapy for brain aneurysms. The first patient procedure was performed at NYU Langone Health. This device, a market leader for a decade, reduces thrombogenicity, facilitating better delivery through complex vascular anatomy. Clinical results show a 77.2% complete aneurysm occlusion rate at 12 months, and improvements in safety and efficacy. The advancement marks a significant milestone in treating cerebral aneurysms, aiming to improve patient outcomes.

Medtronic plc (NYSE:MDT) announced 24-month results from the IN.PACT AV Access clinical study, revealing the IN.PACT™ AV drug-coated balloon (DCB) as the first DCB to demonstrate sustained effectiveness compared to standard PTA in patients with end-stage renal disease. Key findings include a target lesion primary patency of 52.2% for the DCB group versus 36.2% for PTA (p<0.001). Additionally, the study showed 39.5% access circuit primary patency for the DCB group compared to 25.4% for PTA (p<0.001). These results suggest that the IN.PACT AV DCB can reduce the need for reinterventions, enhancing patient quality of life.