Boston Scientific Corp., has announced that it has abandoned its plans to acquire M.I. Tech Co. Ltd., of South Korea after opposition was announced by the U.S. Federal Trade Commission (FTC). The FTC lauded the news with a May 24 statement that cited the agency’s cooperation with other national regulatory authorities as a factor in scotching the proposed acquisition, the second time in recent weeks that government agencies have grounded mergers and acquisitions in the med-tech space.
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.
Recent developments may seem to have rendered artificial intelligence (AI) little more than the latest internet sensation, but a presentation at this year’s annual meeting of the Heart Rhythm Society confirms yet again that AI is much more than just a trend. A new AI algorithm paired with a single-lead electrocardiogram accurately predicted the onset of ventricular tachycardia in 88% of patients in an outcome that could enable cardiologists to thwart thousands of sudden cardiac death (SCD) events each year, potentially ushering in a new age of cardiac care across the globe.
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.
Med-tech companies are facing a new reality of high interest rates, inflation, bank failures, and geopolitical turmoil that are impacting financing and M&A opportunities. To secure finance and attract partnership deals they must keep their product simple, focus on proof of concept and ensure that it has quality, delegates at the LSX World Congress in London heard during a panel presentation.
Getinge AB received U.S. FDA premarket approval (PMA) for its Icast covered stent system, which has been used by clinicians for 20 years under the brand name Advanta V12. Icast is designed to treat patients with iliac arterial occlusive disease, a type of peripheral arterial disease where atherosclerosis narrows and blocks peripheral arteries.
The U.S. CMS has a few changes in mind for the new technology add-on program (NTAP) for fiscal year 2024, including a proposal to allow manufacturers to apply for an NTAP payment only after the sponsor has filed a completed premarket application with the FDA. Perhaps more significantly, the deadline for FDA approval would also be moved up earlier in the calendar year, from July 1 to May 1, a change that could eliminate a year of NTAP eligibility for a significant number of products.
Scivita Medical Technology Co. Ltd. formed a long-term partnership with Boston Scientific Corp. to commercialize Scivita Medical's single-use percutaneous choledochoscope in China. This collaboration will increase the market penetration rate of the product.
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.
