Medtronic plc - MDT STOCK NEWS

Medtronic plc (NYSE: MDT) has launched the InPen™, the first FDA-cleared smart insulin pen integrated with real-time Guardian Connect™ CGM data. This system allows users to view glucose readings and insulin dose information in a single app, simplifying diabetes management. The launch follows Medtronic's acquisition of Companion Medical in September 2020, broadening its product offerings. This innovation aims to enhance user experience and dosing decisions for individuals on multiple daily injections (MDI).

Medtronic (NYSE:MDT) announced FDA 510(k) clearance for its NIM Vital™ nerve monitoring system, enhancing surgical precision during head and neck procedures. This system aids in identifying and monitoring nerve function to mitigate risks. Additionally, Medtronic acquired Ai Biomed Corp., maker of the PTeye™ system, further improving its ENT portfolio. The PTeye system confirms parathyroid tissue during thyroid surgeries, crucial for patient safety. The acquisition is expected to be accretive to Medtronic's ENT business following an immaterial first-year impact.

Medtronic plc (NYSE:MDT) announced FDA approval for its Abre™ venous self-expanding stent system, aimed at treating symptomatic iliofemoral venous outflow obstruction. This device addresses deep venous obstruction, which can lead to serious conditions like blood clots. The approval is based on 12-month results from the ABRE clinical study, which showed a low major adverse event rate of 2.0% and an 88.0% primary patency rate at one year. The stent is designed to offer strength and flexibility, crucial for treating a challenging patient population.

Medtronic plc (NYSE:MDT) announced significant 12-month results from a multicenter randomized controlled trial, validating DTM™ Spinal Cord Stimulation (SCS) therapy's effectiveness for chronic back pain. At 12 months, 84% of DTM SCS patients reported at least 50% pain relief, versus 51% for conventional SCS (p=0.0005). Notably, 69% of DTM SCS patients experienced profound relief (>80% VAS score reduction) compared to 35.1% with conventional therapy. The study underscores the potential advantages of DTM SCS and its novel approach in pain management.

Medtronic (NYSE: MDT) announced promising results from the IN.PACT BTK Study, a feasibility trial evaluating the IN.PACT 0.014 drug-coated balloon (DCB) for treating critical limb ischemia (CLI) patients with chronic total occlusion. Conducted across nine sites in Europe, the study showed a significant reduction in late lumen loss at nine months for the DCB group compared to the conventional angioplasty group (0.59mm vs. 1.26mm, p=0.017). Safety outcomes were comparable for both groups. The study reflects Medtronic's commitment to advancing treatment for critical vascular conditions.

Medtronic (NYSE:MDT) has partnered with The Foundry to develop a cutting-edge transcatheter mitral valve repair technology, with the resulting company, Half Moon Medical, now ready for an early feasibility study, recently approved by the FDA.

This technology addresses severe mitral regurgitation, affecting about 4 million U.S. patients. The Half Moon device aims to restore valve function and could complement Medtronic's existing Intrepid valve system, enhancing their product portfolio in minimally invasive heart therapies.

Medtronic (NYSE:MDT) announces the SMART trial, a head-to-head study of its Evolut™ TAVR system against Edwards' SAPIEN 3 valves for patients with severe symptomatic aortic stenosis. Enrolling 700 patients, it focuses on small annuli and TAV-in-SAV procedures, representing over 40% of the TAVR market. Additionally, Medtronic plans the Evolut™ EXPAND TAVR I feasibility study for moderate and asymptomatic severe aortic stenosis patients, targeting 150 participants. This aims to address a significant patient group, as over 2 million in the U.S. live with these conditions.

Medtronic recently highlighted its growth strategy during the virtual 2020 Investor Day, aiming for accelerated revenue growth and sustainable double-digit total shareholder returns. CEO Geoff Martha emphasized an industry-leading pipeline of innovative products, including the Micra™ AV pacing system and soft tissue surgical robot. Medtronic targets annual organic revenue growth of over 5% and adjusted earnings per share growth of over 8%. The company also expects to maintain a cash conversion ratio greater than 80%, aiming to return more than 50% of free cash flow to shareholders.