As Medtronic plc. is fond of pointing out, the garage inventor has been the stuff of legend in U.S. business lore, providing a wide range of economically impactful inventions over the two-plus centuries since the U.S. patent system came into being.
Medtronic plc has scored a CE mark for its Affera mapping and ablation system for atrial arrhythmias, mere months after acquiring the technology from cardiac solutions company Affera Inc. The dual-use system, which includes the Sphere-9 catheter and Affera Prism-1 mapping software, will be available in Europe beginning in the first half of 2023.
Andera Partners and Novo Holdings A/S led a financing round which raised $25 million for Fire1 Ltd. and will accelerate the development of the company’s remote monitoring technology that improves outcomes for heart failure patients. Andera and Novo are new investors in Fire1 and were joined in the fundraising round by existing investors Gilde Healthcare, Gimv, the Ireland Strategic Investment Fund, Lightstone Ventures, Medtronic plc, New Enterprise Associates and Seventure Partners.
Pulsed field ablation (PFA) may not be the final word where energy sources for atrial fibrillation (AF) ablation are concerned, but several companies have adopted development programs that propose the use of PFA as an alternative to conventional energy sources. Dublin-based Medtronic plc appears to have at least a narrow lead over the competition in the PFA space thanks to the results of the PULSED AF pivotal study presented at the 2023 American College of Cardiology Scientific Sessions.
Surgical aortic valve replacement (SAVR) devices are widely believed to be considerably more durable than transcatheter aortic valve replacement (TAVR) devices, but five-year data for Medtronic plc’s Corevalve Evolut, presented this week at the Cardiovascular Research Technologies Conference in Washington, seem to suggest that TAVR devices are closing that gap.
While still pending clearance in the U.S., Medtronic plc’s Minimed 780G advanced hybrid closed loop (AHCL) system continues to post strong results in clinical trials. Results of two studies presented at the 2023 Advanced Technologies & Treatments for Diabetes Conference in Berlin on Feb. 27 demonstrated that patients with type 1 diabetes (T1D) who used the device for one year maintained a 26.7% increase in time in range for adults and a 14% increase in time in range for children aged 7 to 17 compared to their baseline using multiple daily injections with a continuous glucose monitor (CGM).
Medtronic plc recently received the CE mark for its Aurora extravascular implantable cardioverter-defibrillator (EV-ICD) strengthening its cardiovascular portfolio which saw a 7% year-on-year growth in the third quarter of its fiscal year 2023.
The patent wars over the design of transcatheter aortic valve replacement (TAVR) devices seemed to disappear roughly nine years ago, but there is at least one more episode for Dublin-based Medtronic plc before the company could lay the issue to rest. A jury declared that Medtronic is liable for more than $100 million in damages over alleged infringement of a patent held by Broomfield, Colo.-based Colibri Heart Valve LLC, but the contested patent has expired, and Medtronic said it intends to pursue the matter further.
Globus Medical Inc. entered into a definitive agreement to buy Nuvasive Inc. in an all-stock transaction that will combine two leaders in the musculoskeletal industry into one of the largest companies in the spinal surgery market. While there are many companies in the spine market, the acquisition may still set off an alarm among regulators concerned about consolidation in the field. Both boards unanimously approved the deal.
The U.S. FDA has posted or updated several recalls in the second half of January 2023, such as the class I recall of Mahurkar hemodialysis catheters distributed by Medtronic plc., reported Jan. 30. This recall is associated with two injuries but no fatalities to date, but the potential for mixing of venous and arterial blood has forced Medtronic to request that its customers quarantine any unused catheter kits, which could be a substantial amount of product given the nearly 23,000 units are affected by the recall.
