The annual volume of implant of transcatheter aortic valve replacement (TAVR) devices has grown steadily over the years, and that volume might sustain its upward trajectory over the next few years if the results of a new analysis of more than 46,000 TAVR patients gain traction. The data for these patients with minimally symptomatic aortic stenosis (AS) predictably indicated that this group was less susceptible to bad outcomes than those with more severe symptoms, but one of the hopes is that earlier intervention into AS could ward off future cardiovascular events, a finding which might justify expanded payer coverage for TAVR in these patient populations.
Gradient Denervation Technologies SAS closed a €14 million (US$15 million) series A financing round that will help the company with the ongoing clinical development and evaluation of its ultrasound-based catheter device to treat pulmonary hypertension. The financing round was led by Asabys Partners, with participation from Thuja Capital and founding investor Sofinnova Partners.
Pacira Cryotech Inc. reported the filing of a patent for a hand-held cryogenic treatment system with a probe configured to apply a cryogenic therapy to one or more nerves, such as the nerves of the stellate ganglion and autonomic tissue peripheral to the stellate ganglion.
When the data and safety monitoring board (DSMB) for Biocardia Inc.’s phase III pivotal trial of its Cardiamp cell therapy for heart failure advised pausing the study in July to analyze the interim results, the company expressed confusion as there were no reported treatment-emergent safety issues and aggregated blinded data showed better than expected outcomes. With the recommended external analysis now complete, the company confirmed the study is unlikely to achieve its primary endpoint at one year. The trial has now been unblinded.
The pivotal ADVENT trial of the Farapulse pulsed field ablation (PFA) system developed by Boston Scientific Corp. returned positive results at one year, according to a presentation at the ESC Congress 2023 that was simultaneously published in the New England Journal of Medicine. The study compared Farapulse, a nonthermal treatment that ablates heart tissue, to radiofrequency or cryoablation, the current standards of care for paroxysmal atrial fibrillation.
Four months after raising $55 million, Magenta Medical Ltd. reported the completion of enrollment to a U.S. FDA-approved early feasibility study with the Elevate percutaneous left ventricular assist device (pLVAD).
Magassist Co. Ltd. has been granted a breakthrough device designation by the U.S. FDA for its interventional ventricular assist device (VAD), which is expected to accelerate the development and approval of the product.
Medtronic plc presented 10-year results from its ongoing trial comparing transcatheter aortic valve implantation with surgical aortic valve replacement. The results support use of the Medtronic Corevalve platform for lower risk of severe valve deterioration compared to surgical replacement.
The U.S. FDA has given Aquedeon Medical Inc. the green light to conduct an IDE clinical trial of its Duett vascular graft system. The device is designed to improve outcomes in surgical thoracic aortic procedures by simplifying treatment of target vessels and reducing overall procedure time.
Dublin-based Medtronic plc. has invested considerable resources into its renal denervation program, but the company has not completed its regulatory journey for the U.S. market just yet. Medtronic failed to persuade an FDA advisory committee of the virtues of its Symplicity Spyral device due to inconsistent results from the two major studies presented at the hearing but vowed to keep working on the application despite the sustained headwinds.
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