Medtronic plc posted solid fiscal year second-quarter results led by the cardiovascular business with 9.3% growth. The Affera Sphere-9 pulsed field ablation system tripled the company’s sales in the hot PFA segment and pushed the cardiac ablation solutions unit to 71% growth, a nice uptick from the nearly 50% seen in its Q1.
Minze Health NV signed a three-year agreement with Medtronic plc to bring its Minze Diary Pod, an app-controlled automated urine collection device, to markets across the EMEA region. The partnership aims to enhance the support services available for patients with overactive bladder receiving sacral neuromodulation therapy with Medtronic’s Interstim system.
The U.S. CMS has confirmed that it will cover renal denervation as a treatment for hypertension in a final coverage memo that largely mirrors the July 2025 draft. One key difference, however, is that Medicare beneficiaries are eligible for RDN after only six weeks of optimized medical therapy, half the three-month waiting period described in the draft.
Medtronic plc’s SPYRAL HTN-ON MED trial demonstrated significantly greater reduction in blood pressure with the Symplicity Spyral renal denervation procedure at three years than a sham procedure in a study presented as featured clinical research at the 2025 Transcatheter Cardiovascular Therapeutics conference in San Francisco.
Vektor Medical Inc. recently secured CE mark for Vmap, its AI-powered electrocardiogram mapping system, marking a “major milestone” for the company, said CEO Rob Krummen. The regulatory approval from the EU authorities confirms that Vmap meets the stringent safety and performance requirements of the EU Medical Device Regulation, opening the door for clinical use in Europe, he told BioWorld.
Medtronic plc’s Brainsense adaptive deep brain stimulation system has been shown to be tolerable, effective and safe for long-term use at home in people with Parkinson’s disease. A study published in the Journal of the American Medical Association (JAMA) Neurology found that the majority of participants who received aDBS with the Percept neurostimulator achieved good ‘on-time’ without troublesome dyskinesia compared to standard continuous DBS therapy.
Convatec Group plc plans to invest more than $1 billion in the U.S. and U.K. over the next decade as it looks to accelerate its research and development (R&D) ambitions.
Medtronic plc received U.S. FDA approval for Altaviva, a minimally invasive implantable tibial neuromodulation device designed to treat urge urinary incontinence. Insertion near the ankle requires neither sedation nor imaging and patients walk out the clinic door with the device already activated.
Kardium Inc.’s Globe pulsed field system received U.S. FDA premarket approval, making it the fourth PFA system in the rapidly expanding market for cardiac ablation for atrial fibrillation. The system’s introducer sheath and mapping software also received clearance.
