The U.S. FDA has granted Sonivie Ltd. IDE approval for a pilot study to treat resistant hypertension patients with renal artery denervation (RDN) using its Tivus ultrasound ablation system. The intravascular, catheter-based system uses high-frequency non-focused ultra-sound energy to ablate nerves in the renal artery and cause denervation of nerves in other structures such as the bronchus.
Penumbra Inc. presented new data at the LINC Symposium in Leipzig, Germany, evaluating its Indigo aspiration system for submassive pulmonary embolism (PE). The subgroup analysis evaluated performance outcomes of patients with main pulmonary artery (PA) emboli vs. discrete unilateral or bilateral PA emboli without main PA involvement. Data from the study suggests the system can be used effectively for both proximal and distal aspiration thrombectomy in the pulmonary arteries.
Jenavalve Technology Inc. presented first real-world data for a study evaluating the safety and efficacy of its Jenavalve Trilogy transcatheter aortic valve implantation (TAVI) system for the treatment of severe aortic regurgitation (AR). The data, presented at the EuroPCR meeting on May 18, met the primary safety and efficacy endpoints with no major adverse events and no moderate or severe AR at discharge.
Four months after debuting W1 health watch at Arab Health 2022, Masimo Corp. reported a limited release of the consumer version of the device in the U.S. to 10,000 users on a first come-first served basis. The wrist-worn device, which measures oxygen saturation, pulse rate, perfusion index, pleth variability index and respiration rate, also counts steps and detects falls.
Hello Heart Inc. more than doubled its fundraising to date with a $70 million series D financing round showing heart-warming support from investors for its digital therapeutic solution. Growth equity firm Stripes led the round, which brought the heart-focused digital therapeutic company’s total raised to date to more than $138 million.
Acutus Medical Inc. is selling its left-heart access portfolio to Medtronic plc in a deal worth upwards of $50 million. The portfolio of devices includes a line of sheath-compatible septal crossing devices and steerable sheaths. Under the terms of the agreement, Medtronic will make an upfront cash payment to Acutus of $50 million and additional undisclosed payments based on milestones and future sales.
Digital health company Recora Inc. has surfaced from stealth mode with $20 million in series A funding to advance its comprehensive care management vision for heart disease patients.
The FDA cleared a peripheral vascular occlusion product developed by Artio Medical Inc. The Solus Gold embolization device is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.
A large health system in Minnesota recently became the first in the world to have completed a structural heart procedure, or any other surgical procedure for that matter, using any kind of 4D hologram technology. The technology was developed by venture capital-backed startup Echopixel Inc., and it is intended to improve both surgical precision and outcomes in minimally invasive procedures.
The history of Medicare coverage of transcatheter aortic valve replacement (TAVR) devices has not lacked for controversy despite the massive positive impact on outcomes. Ashwin Nathan, of Hospital of the University of Pennsylvania, said a new analysis made clear that the expansion of centers qualified to perform TAVR procedures has been nearly all in high population density areas with an existing TAVR program, thus leaving out the still-forgotten rural patient.
