Medtronic plc has unveiled its latest buy this year with the planned acquisition of Avenu Medical Inc., which focuses on the endovascular creation of arteriovenous (AV) fistulae for patients with end-stage renal disease (ESRD) undergoing dialysis. The two did not disclose the terms of the transaction.
The U.S. Centers for Medicare & Medicaid Services (CMS) recently proposed some changes to national coverage policies for left ventricular assist devices (LVADs) and artificial hearts, the latter of which would no longer be covered under a national coverage determination. The proposal to allow Medicare administrative contractors (MAC) to make coverage decisions for artificial hearts on a case-by-case basis clanged across both industry and medical societies, which cited data collection problems and inequalities in access as reasons the existing coverage policy should remain in place.
The U.S. FDA has granted breakthrough device designation status to Medtronic plc’s Tyrx absorbable antibacterial driveline wrap, a medical device aimed at reducing driveline complications in patients receiving a ventricular assist device (VAD).
Medtronic plc is celebrating its latest win following the U.S. FDA’s approval of an early feasibility study (EFS) of the Intrepid transcatheter tricuspid valve replacement system in patients with severe, symptomatic tricuspid regurgitation. The action comes after the agency granted breakthrough device designation for the system.
Cryoablation for paroxysmal atrial fibrillation (PAF) is not the standard of care, but a recent study may change at least some clinicians’ thinking on that score.
Medtronic plc reported first-quarter worldwide revenue of just over $6.5 billion, a decrease of 13% as reported. As Cowen’s Josh Jennings wrote, the company’s results were better than expected, with an organic revenue growth decline of 17% vs. the Street’s prediction of a 25% decrease.
Medtronic plc is highlighting the publication of primary endpoint results from the In.Pact AV Access trial in the New England Journal of Medicine. The study found that the company’s paclitaxel-coated balloon limits the number of reinterventions needed to maintain blood flow in patients with end-stage renal disease who have arteriovenous fistulae.
In a single draft coverage memo, the U.S. Centers for Medicare and Medicaid Services (CMS) proposed to eliminate national coverage for artificial hearts and to provide coverage of ventricular assist devices (VADs) coverage for those in need of short-term ventricular support. Coverage of artificial hearts would thus revert to Medicare administrative contractors, while the change in VAD coverage would resolve a long-running dispute between cardiologists and the agency.
Medtronic plc has won U.S. FDA approval of its Interstim Micro rechargeable sacral nerve stimulator and Interstim Surescan MRI leads for the treatment of urinary and bowel dysfunctions. The new products make Medtronic the only company to offer a choice between rechargeable and recharge-free sacral neuromodulation (SNM) systems, allowing patients to align their treatment with personal lifestyle preferences.
Robotic-assisted surgery-focused Intuitive Surgical Inc. revealed its second-quarter results late July 21, with worldwide Da Vinci procedures falling about 19% vs. the same period of 2019. Driven by this decline, second quarter 2020 instruments and accessories (I&A) revenue fell by 20% to $461 million, vs. $579 million in the second quarter of 2019.
