Renal denervation (RDN) was described as the “comeback kid” at the recent EuroPCR conference in Paris where participants argued that following the success seen in several sham-controlled trials, there is now no doubt about the safety and the efficacy of the technology as a treatment for hypertension. The device-based procedure should now be used as a therapy option to reduce high blood pressure in patients, delegates heard.
Medtronic plc agreed to acquire Eoflow Co. Ltd., the manufacturer of Eopatch, a tubeless, wearable and fully disposable insulin delivery service, for $738 million. The deal, which is expected to provide a significant boost to Medtronic’s beleaguered diabetes unit, is slated to close in the second half of 2023. The deal announcement coincided with Medtronic’s release of its fourth quarter results for fiscal 2023.
Patent disputes over medical technology exert a significant influence on a company’s fortunes in the marketplace, and a recent decision by the U.S. Court of Appeals for the Federal Circuit reinforces yet again the importance of patent protection for device manufacturers. In a decision filed May 24, the Federal Circuit decreed that patents for catheters held by Teleflex Innovations were not rendered ineligible by what Dublin-based Medtronic plc had asserted was prior art, thus dealing Medtronic a blow in its efforts to have the five Teleflex patents in question rendered null.
Bringing both ventricles back into synchrony has long been the subject of cardiological hopes in patients with heart failure, but current approaches to maximizing the function of the left ventricle leave many patients in a desperate state of cardiac dyssynchrony. However, Ebr Systems Inc., has reported the results of a study that demonstrates that its WiSE device can pace the left ventricle in patients who are unresponsive to conventional pacing in an effort to restore optimal left ventricular function, a development Sunnyvale, Calif.-based Ebr says will allow the company to conclude a premarket filing with the U.S. FDA.
Pulsed field ablation (PFA) seems to have seized the moment in the field of cardiac electrophysiology, given its seemingly superior performance over other ablation modalities as a treatment for atrial fibrillation (AF). New data from three studies were presented at this year’s annual meeting of the Heart Rhythm Society that further confirm the value of PFA as a treatment for both persistent and paroxysmal AF with data sets that seem to confirm that PFA is poised to sweep aside the current standards for ablation, potentially overturning a treatment paradigm that took decades to establish.
Elixir Medical Corp. reported that the Bioadaptor randomized controlled trial which compared its Dynamx coronary drug-eluting bioadaptor system to Dublin-based Medtronic plc’s Resolute Onyx drug-eluting stent (DES) in de novo native coronary arteries, met its primary endpoint of target lesion failure (TLF) non-inferiority at 12 months. The results were presented at a late-breaking clinical session during the EuroPCR 2023 conference in Paris.
It has become apparent that introducing two stents into the body to treat a patient with a bifurcation disease is not necessary and can be harmful, David Hildick-Smith, the lead investigator in a study, told delegates at the EuroPCR conference in Paris. Presenting late-breaking clinical data of three-year follow up results of different stenting strategies in patients with true left main stem bifurcation lesions, Hildick-Smith said that the results showed that only one in five patients needed a second stent.
An increasing number of European med-tech companies are first seeking regulatory approval from the U.S. FDA because of the growing backlog and frustrations with requirements under the new regulatory framework of the EU Medical Device Regulation (MDR), which has been described as “not working.”
The FDA gave the greenlight to Route 92 Medical Inc. for its Freeclimb 70 reperfusion system in the treatment of ischemic stroke. The 510(k) clearance includes a Freeclimb 70 aspiration catheter, as well as a Tenzing 7 delivery catheter.
Companies such asMedtronic plc have become risk averse and are unlikely to takeover early stage medtech firms, Ori Hadomi, vice president strategic initiatives & partnerships, at Medtronic, told delegates at the LSX World Congress in London. Hadomi, who joined Dublin-based Medtronic after his firm Mazor Robotics Inc. was taken over by the company in a $1.64 billion deal in 2018, told early-stage startups “don’t waste their time” in approaching the company.
