Anteris Technologies Ltd. raised AU$35 million (US$24.21 million) to fund clinical development of its 3D single-piece prosthetic heart valve implant, the Duravr, for the treatment of aortic stenosis.
Abbott Laboratories reported its plans to acquire Cardiovascular Systems Inc., (CSI), makers of an orbital atherectomy system, and will pay shareholders of CSI $20 per share. Analysts see the acquisition as a smart move for Abbott even though the purchase price represents a 50%-plus premium over the Feb. 8 closing price of $13.31, but the companies did not provide a date by which the transaction will close.
Truleaf Medical Ltd., a subsidiary of Israel-based Allmed Solutions, is ready to begin human trials of its Rosedoc platform to replace the heart’s leaky mitral valve using cardiac catheterization.
Shenzhen Core Medical Technology Co. Ltd. completed a series C round to speed up the development of its left ventricular assist devices (LVAD) for heart failure.
The U.S. FDA has given the green light to Abbott Laboratories Inc. for its Navitor next-generation transcatheter aortic valve implantation (TAVI) system for the treatment of patients with aortic valve stenosis who are at increased risk of open-heart surgery. Abbott won European approval of Navitor in May 2021.
Sonoscape Medical Corp. obtained marketing approval in China for its intravascular ultrasound (IVUS) diagnostic device and intravascular ultrasound diagnostic catheter.
Shanghai Microport Endovascular Medtech Co. Ltd.’s Hercules balloon dilation catheter has been approved for marketing approval in China to be used in endovascular aneurysm repair (EVAR) procedures.
The U.S. FDA reported that the post-approval study (PAS) for the Impella RP by Abiomed Inc. of Danvers, Mass., demonstrated that the device performed well for patients who would have been eligible for the pivotal study, providing a 69.7% survival rate at 30 days after device explant.
Lepu Medical Technology (Beijing) Co. Ltd. has been given the green light from China’s NMPA for its disposable micro-guidewire. Beijing, China-based Lepu Medical confirmed to BioWorld that this micro-guidewire was approved for fractional flow reserve (FFR) measurements in adult patients with coronary artery lesions during coronary angiography and interventional procedures.
Results from the largest trial yet in transcatheter valve replacement continues to demonstrate strong results for Edwards Lifesciences Corp.’s Evoque system. A late-breaking presentation at the PCR London Valves 2022 meeting provided one-year follow-up results from the Triscend study showing better than 90% survival and 99% freedom from heart failure hospitalization. Further, 97.6% of patients maintained mild or trace tricuspid regurgitation.
