Medtronic plc’s SPYRAL HTN-ON MED trial demonstrated significantly greater reduction in blood pressure with the Symplicity Spyral renal denervation procedure at three years than a sham procedure in a study presented as featured clinical research at the 2025 Transcatheter Cardiovascular Therapeutics conference in San Francisco.
Boston Scientific Corp. handily beat expectations for sales growth and profits in the second quarter, led by 117% growth for its Farapulse pulsed field ablation system in the U.S. and 23% overall organic increase in revenue for cardiology. The company cut the expected impact of tariffs by 50% and raised guidance for earnings per share and sales for the year.
Boston Scientific Corp. agreed to acquire Sonivie Ltd., developer of a therapeutic intravascular ultrasound system for denervation to treat resistant hypertension, pulmonary hypertension and chronic obstructive pulmonary disease. On a 100% basis, the deal is valued at $600 million with $400 million up front and $200 million upon achievement of a regulatory milestone.
Andera Partners involvement in a string of recent deals in the cardiovascular space demonstrates the ongoing appetite for devices to treat heart diseases, Olivier Litzka, a partner at Andera Partners told BioWorld.
There is no doubt that the fundraising environment in Europe remains challenging for med-tech companies. Currently it seems like “the winner takes it all,” with companies that have de-risked their portfolio able to find investors to provide funds, while for those at the earlier stages, finding capital continues to be ‘tricky,’ Raphaël Wisniewski, partner at European private equity firm Andera Partners, told BioWorld in an interview.
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.
Heartpoint Global Inc. will begin human trials of its Intellistent device shortly and expects to make submission to the U.S. FDA in 2024, Seth Bogner, its chairman and CEO told BioWorld in an interview on the sidelines of the EuroPCR conference in Paris. Intellistent is a multi-lumen stent system for interventional adjustment of pulmonary blood flow in congenital heart disease. It is a minimally invasive device that will meet an unmet need in pulmonary artery hypertension caused by congenital heart disease, said Bogner.
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.
Sonivie Ltd. has won breakthrough device designation from the U.S. FDA for the Therapeutic Intra-Vascular Ultrasound (TIVUS) system for renal artery denervation (RDN) to treat resistant hypertension. At the same time, the company revealed that it has bought the remaining intellectual property and other assets related to the use of the TIVUS System from Cardiosonic Inc.
Aria CV Inc., which focuses on pulmonary arterial hypertension (PAH), has won a breakthrough device designation from the U.S. FDA for the Aria CV pulmonary hypertension (PH) system. The implanted Aria CV PH system aims to restore the benefits of a healthy, elastic pulmonary artery, which in turn reduces cardiac workload and enhances blood flow.
