Medtronic plc - MDT STOCK NEWS

Medtronic (NYSE: MDT) has received FDA approval for its Affera™ Mapping and Ablation System with Sphere-9™ Catheter, making it the first company with two pulsed field ablation (PFA) technologies for atrial fibrillation treatment. The system combines high-density mapping with dual energy (pulsed field and radiofrequency) ablation capabilities for treating persistent atrial fibrillation and atrial flutter. The Sphere-9 catheter features a 9mm lattice tip and enables physician treatment flexibility with its wide area focal design. The approval follows successful results from the SPHERE Per-AF study and previous CE Mark and Australian approvals.

Medtronic employees surprised 200 students in Columbia Heights with new bikes, locks, and helmets. This donation was part of a volunteer effort where hundreds of Medtronic employees built the bikes. The initiative continues the legacy of Medtronic's founder, Earl Bakken, who grew up in Columbia Heights and inspired employees to contribute to their communities.

This bike donation is one of many efforts by Medtronic to create lasting change in communities. The company encourages its employees to give back and make an impact across various communities, following Bakken's vision of community involvement.

Medtronic (NYSE: MDT) has issued a voluntary recall for its MiniMed™ 600 and 700 series insulin pumps due to potential risks of shortened battery life. The recall, initiated on July 31, 2024, urges users to monitor built-in alerts and alarms for battery status and contact Medtronic for replacements if battery life issues are observed. The issue stems from internal electrical component damage caused by drops or impacts, leading to premature battery depletion. This can result in the pump stopping insulin delivery earlier than expected, posing health risks like hyperglycemia or diabetic ketoacidosis (DKA). From January 2023 to September 2024, there were 170 reports of hyperglycemia and 11 reports of DKA in the U.S. related to this issue. The FDA has classified this recall as a class I recall. Medtronic advises users to carry extra batteries and contact support if they notice significant battery life reduction.

Medtronic plc (NYSE: MDT) announced new clinical data for its PulseSelect™ Pulsed Field Ablation (PFA) System in treating atrial fibrillation (Afib). The study, presented at the Asia Pacific Heart Rhythm Society (APHRS) meeting, showed high rates of durable lesion formation:

- 98% of pulmonary veins remained isolated
- 96% of patients had all veins isolated

These results were observed approximately two months post-ablation. Dr. Devi Nair, Director of Cardiac Electrophysiology & Research at St. Bernard's Medical Center, emphasized the importance of this real-world evidence for the electrophysiology community as PFA use increases rapidly. The data adds to previous evidence establishing the safety and effectiveness of the PulseSelect technology.

Medtronic plc (NYSE: MDT) announced new advancements in its AiBLE™ spine surgery ecosystem at the North American Spine Society Annual Meeting. The company introduced several innovations:

1. O-arm™ 4.3 software with advanced navigation volumes, dose reduction, and enhanced image confirmation.

2. UNiD™ Adaptive Spine Intelligence now includes MRI Vision for automated lumbar MRI analysis.

3. Mazor™ robotic guidance system with 5.1 software, introducing Maximum Intensity Projection.

4. ModuLeX™ Spinal System, the next generation of the CD Horizon™ product family.

Medtronic also announced a partnership with Siemens Healthineers to integrate the Multitom Rax™ imaging system into the AiBLE™ ecosystem, aiming to advance clinical outcomes in spine surgery.

Medtronic plc (NYSE:MDT), a global healthcare technology leader, announced its participation in the 2024 Wells Fargo Healthcare Conference on September 4, 2024. Geoff Martha, Medtronic's chairman and CEO, will engage in a Q&A session about the medtech industry and the company at 11:55 a.m. EDT. A live webcast will be available on Medtronic's investor relations website, with an archive accessible later that day.

Headquartered in Galway, Ireland, Medtronic is at the forefront of addressing global health challenges. With a workforce of 95,000+ across 150+ countries, the company develops technologies and therapies for 70 health conditions, including cardiac devices, surgical robotics, and patient monitoring systems. Medtronic's mission is to alleviate pain, restore health, and extend life, delivering innovative solutions that transform lives every second.

PaceMate®, a leader in cardiac data management and remote monitoring, has acquired Medtronic's Paceart Optima™ system, an on-premises cardiac workflow solution. This strategic move expands PaceMate's global reach by adding nearly 1,000 clinic locations worldwide. The acquisition enhances PaceMate's position as the preferred partner in advanced cardiac data management, offering a comprehensive end-to-end platform supporting various cardiac device types.

Key points:

• Medtronic (NYSE: MDT) and PaceMate will collaborate for a seamless transition
• Paceart employees will transition to PaceMate, ensuring continued support
• PaceMate's flagship product, PaceMateLIVE™, is recognized as best-in-class remote cardiac monitoring software
• The acquisition aims to set new standards in cardiac care and enable better patient outcomes and global innovation

Medtronic is addressing technology bias in pulse oximeters, which may not accurately measure oxygen levels across all skin tones. The company has taken steps to improve device accuracy, including:

1. Participating in an FDA panel on pulse oximeter accuracy
2. Opening a physiology lab in a diverse Denver neighborhood for inclusive clinical trials
3. Conducting its own clinical trials to innovate quickly

Medtronic's Nellcor pulse oximeter missed 7.9% of hypoxemic events in a recent study, compared to 30% for a competitor's device. The company aims to reduce this to zero, regardless of skin type or perfusion. The new lab has enrolled over 130 diverse participants, focusing on equity in healthcare technology.

Medtronic (NYSE: MDT) reported its Q1 FY25 financial results, ending July 26, 2024. Revenue was $7.9 billion, with an adjusted revenue of $8.0 billion, up 2.8% as reported and 5.3% organically. GAAP diluted EPS increased to $0.80, while non-GAAP diluted EPS rose to $1.23. The company raised its FY25 organic revenue growth guidance to 4.5%-5% and EPS guidance to $5.42-$5.50.

Key growth drivers included the MiniMed™ 780G automated insulin delivery system for Diabetes, and the Percept™ RC deep brain stimulator for Neuromodulation. Cardiovascular revenue grew by 5.5% as reported and 6.9% organically. Neuroscience revenue increased by 4.4% as reported and 5.3% organically.

Despite strong performance, foreign currency translation had a negative impact of $90 million on revenue and reduced non-GAAP diluted EPS by 6 cents. Medtronic executives are optimistic about sustained growth driven by new product innovations.