Irvine Calif.-based Inari Medical Inc. reported results from what it described as the largest prospective study of interventional treatment in high-risk pulmonary embolism (PE), which found a 90% survival improvement in high-risk pulmonary embolism using the company’s Flowtriever System. Data from the FLAME (Flowtriever for Acute Massive Pulmonary Embolism) study in high-risk PE was presented at the 2023 American College of Cardiology (ACC) conference on March 5.
Device durability for transcatheter aortic valve replacement (TAVR) devices remains topical for patients, payers and regulators, but the standard measure of 10-year data were difficult to obtain for the first decade after the FDA first approved a TAVR device in 2011.
New data presented at the Cardiovascular Research Technologies (CRT) 2023 meeting reinforced the safety and effectiveness of Boston Scientific Corp.’s Watchman FLX left atrial appendage occlusion (LAAO) device in routine, real-world clinical care. Building on positive 45-day outcomes presented at CRT 2022, the analysis shows sustained low stroke rate at one year, including ischemic stroke.
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.
Tricuspid valve regurgitation has lagged mitral regurgitation where device development is concerned, but new one-year data from the TRILUMINATE study of the Triclip device suggests that device therapy is safe and cuts down on regurgitation in a manner that makes the condition much more tolerable for patients. At this point, however, the data do not yet offer much difference when it comes to mortality and rehospitalization compared to medical management, a gap Abbott will have to overcome if it wants to maximize its investment in this underdeveloped area of medical technology.
Abbott Laboratories scored a major win for its Mitraclip device thanks to data from the COAPT study for secondary mitral valve regurgitation. The latest data from this study show a stunning difference in two-year mortality compared to maximized medical management only – 29% on the device versus 46% on medical management – but differences between the COAPT study results and outcomes seen in the MITRA-FR study will force cardiologists to dive into the data to ensure that their patient selection practices account for critical differences in the conduct of these two studies.
The fundraising environment for startups in med tech is expected to continue to be challenging for at least another year as public markets remain closed and private investors favor companies that have already de-risked their products. One of the major issues in the U.K. and Europe is that the IPO markets are “pretty much shut” and “our public markets aren’t working”, therefore companies are having to rely on private funding, with venture capital being one of those sources, said Robert Tansley, partner, at venture capital fund Cambridge Innovation Capital (CIC).
As companies increasingly use artificial intelligence (AI) in medical devices and applications to help treat and diagnose patients, innovators must be careful of excluding large sections of the population in their algorithms and in their data gathering process, delegates heard at the Medtech Futures conference in Cambridge, U.K.
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).