It failed to meet the primary endpoint at six months, but the European chief investigator for Biogen Inc.’s phase III trial of tofersen in treating amyotrophic lateral sclerosis (ALS) now describes the study as “trailblazing,” following a six-month open label extension.
The 2022 Transcatheter Cardiovascular Therapeutics annual meeting highlighted mostly positive outcomes from major trials conducted by nearly all the big players in the cardiac device market. Here’s our round-up of the meeting’s high points, with updates from Abbott Laboratories, Abiomed Inc., Boston Scientific Corp., Edwards Lifesciences Corp., Inari Medical Inc., Medtronic plc and Recor Medical Inc.
Transcatheter aortic valve replacement (TAVR) continues to grow, so it is little surprise that the 2022 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting featured multiple presentations about TAVR-related devices and outcomes. The American College of Cardiology/American Heart Association’s latest guidelines recommends TAVR for patients over age 80 and surgery for those under age 65. Those in the middle can go either way, depending on comorbidities and patient preferences.
Abiomed Inc., has worked the ventricular assist device (VAD) space for a number of years with its Impella series of VADs, and a study coming out of Japan seems to affirm investors’ confidence in these devices. This registry study demonstrated that the combination of Impella devices and extracorporeal membrane oxygenation (ECMO) provides a 30-day survival rate of more than three in four patients with cardiogenic shock, an outcome that is said to support the notion that the native heart tissue can recover from myocarditis, an especially salient consideration for those who contracted the SARS-CoV-2 virus.
In an unexpected turn of events, Medtronic plc presented results from the Symplicity HTN-3 trial at year 3 showed sustained reductions in blood pressure with radiofrequency renal denervation (RDN) for resistant hypertension, contrary to the trial’s results at the six-month mark—and it wasn’t alone in showing positive results for the procedure.
Top-line phase III results showing Hutchmed Ltd.’s targeted therapy fruquintinib reduced the risks of death and disease progression by 34% and 68%, respectively, for patients with metastatic colorectal cancer could “lay a solid foundation for Hutchmed to initiate discussions with regulatory authorities worldwide,” a spokesperson of Hutchmed, told BioWorld.
The May 2014 approval of Takeda Pharmaceutical Co. Ltd.’s Entyvio (vedolizumab) brought welcome news in the form of an important mechanism of action for patients with ulcerative colitis and Crohn’s disease, but also means a burdensome course of administration – 30 minutes’ worth of infusion every six weeks, a drawback that other developers are trying to remedy. Standouts among the up-and-comers are Morphic Holding Inc., with an oral candidate that works through the same mechanism of action as Entyvio, and Protagonist Therapeutics Inc.
Inari Medical Inc. released results from its 800-person Flowtriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) registry in pulmonary embolism (PE) at the 2022 Transcatheter Cardiovascular Therapeutics conference in Boston on Sept. 18 showing that treatment of PE with its Flowtriever device provided immediate hemodynamic and symptom improvement with all-cause mortality rates under 1.0% at 30 days.
Boston Scientific Corp.’s Sentinel cerebral protection system missed its primary endpoint of reduced stroke in the PROTECTED TAVR clinical trial. The data did, however, show a significant reduction in risk of disabling stroke in the immediate days after a transcatheter aortic valve replacement (TAVR) procedure.
One of the biggest stories coming out of Transcatheter Cardiovascular Therapeutics’ annual meeting in Boston this weekend focuses on the success of Edwards Lifesciences Corp.’s freshly FDA-approved Pascal Precision transcatheter valve repair system in the CLASP IID trial, which compared it to Abbott Laboratories’ Mitraclip device in patients with degenerative mitral regurgitation (DMR) who were determined to be at prohibitive surgical risk.
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