The renal denervation hypothesis of hypertension was initially viewed with some skepticism, and Dublin-based Medtronic plc. endured a major setback when clinical trial data failed to make a compelling case for approval for the Symplicity Spyral. However, the company finally landed an FDA approval for the device, opening the gates to a new and significant market opportunity even with competition already on the market.
Surmodics Inc. reported positive two-year data from the SWING trial, the first-in-human study to look at the safety of its Sundance Sirolimus drug-coated balloon (DCB) when used to treat occlusive disease of the infrapopliteal arteries. Results presented at the VEITHsymposium in New York showed that the Sundance Sirolimus DCB demonstrated an excellent safety profile and achieved primary patency of 71.4% at 24 months in the per protocol analysis population.
Researchers from the University of Michigan have filed for patent protection of methods and systems to identify actual esophageal tissue changes and/or damage during cardiac ablation procedures.
Emboline Inc. is seeking patent protection for methods and apparatus for embolic protection during cardiac procedures being performed on atrial outlet valves, namely, the mitral and tricuspid valves.
Acutus Medical Inc. revealed plans after the Nasdaq closing bell on Nov. 8 to abandon the electrophysiology business as part of a massive restructuring that will leave the company entirely committed to manufacturing and distribution of Medtronic plc’s left-heart access products. The shift will put 65% of Acutus employees out of work and leaves the future of its cardiac ablation and mapping products up in the air.
Recor Medical Inc. finally received U.S. FDA approval for its Paradise ultrasound renal denervation (RDN) system for the treatment of hypertension after more than ten years of research and clinical trials. Paradise is the first RDN system to reach the U.S. market, and its approval is good news for the technology after years of disappointment in the data from trials and concerns over the efficacy of RDN devices.
United Therapeutics Corp. signed an agreement to acquire Miromatrix Medical Inc. for up to $140 million in cash, buying its way into additional organic growth. The deal would add Miromatrix’s comprehensive portfolio of bio-engineered organs to United’s existing organ production platform.
One-year results from the CLASP IID trial and registry showed outstanding results in patients with significant symptomatic degenerative mitral regurgitation (DMR) for Pascal, Edwards Lifesciences Corp.’s transcatheter-edge-to-edge repair (TEER) system, in a presentation at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) meeting in San Francisco hosted by the Cardiovascular Research Foundation.
Left atrial appendage (LAA) occlusion procedures are designed to reduce the risk of thromboembolism in patients who have non-valvular atrial fibrillation, but a study presented at the 2023 Transcatheter Cardiovascular Therapeutics annual meeting in San Francisco demonstrated that about half of patients continue to have LAA leaks – and potentially the risk of dangerous blood clots and stroke – a year after the procedure.
The EU approved the first drug-coated balloon for treatment of in-stent restenosis nearly a decade ago, but U.S. physicians continue to have their hands tied in treating the fairly common problem. Results from Boston Scientific Corp.’s investigational device exemption trial for its Agent paclitaxel-coated balloon presented in San Francisco at Transcatheter Cardiovascular Therapeutics could finally put the tool in the hands of cardiologists. The device demonstrated a nearly 50% reduction in the risk of target lesion revascularization and target vessel myocardial infarction compared to conventional balloon angioplasty.
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