Sichuan Jinjiang Electronic Medical Device Technology Co. Ltd. received approval from China’s National Medical Products Administration (NMPA) approval for the commercial use of its PFA technology in the treatment of atrial fibrillation, making it the first pulsed field ablation device to gain approval in the country.
Medtronic plc received the greenlight from the U.S. FDA for its latest deep brain stimulation system, the Percept RC. The rechargeable neurostimulator includes the company’s sensing technology which captures data from brain signals and allows for more personalized therapy.
Boston Scientific Corp. agreed to acquire neurostimulation company Axonics Inc. for $71 per share or $3.7 billion in total. Axonics focuses on stimulation of the sacral neve to treat overactive bladder and bowel dysfunction. It also offers a bulking agent to address stress urinary incontinence in women.
The deal is expected to close in the first half of 2024, pending approval of stockholders and regulators.
Medtronic plc received CE mark for its Percept RC neurostimulator for deep brain stimulation, which the company hopes will transform brain modulation and empower patients in the E.U. with neurological indications. The device is designed to capture and record brain signals and provide clinicians with insights to enable them to adapt and personalize therapy for patients.
The U.K. National Institute for Health and Care Excellence is not utterly opposed to the use of mechanical thrombectomy as a treatment for pulmonary embolism, but the agency believes that the outcomes data for high-risk patients are lacking.
Edwards Lifesciences Corp. set analysts a-spin ahead of its investor day activities with the revelation it plans to launch its critical care unit as a stand-alone public company next year. Edwards expects that dividing the business will allow it to focus on cardiovascular and surgical markets.
The U.S. FDA’s recent approval of Boston Scientific Corp.’s Tenacio pump, a component for its AMS 700 inflatable penile prosthesis (IPP), is an “exciting milestone” for the company, Ronald Morton, chief medical officer, Urology, at Boston Scientific told BioWorld. The AMS 700 IPP is a treatment option for men with erectile dysfunction and is designed to deliver a more intuitive experience for patients when using the device.
Using minimally invasive focal therapies to treat prostate cancer are much more cost-effective and can improve patients’ quality of life compared to surgery or radiotherapy, according to a study published in the Journal of Medical Economics.
Johnson & Johnson completed the previously unheralded acquisition of privately held Laminar Inc. for $400 million upfront, with undisclosed contingent payments depending on achievement of clinical and regulatory milestones starting in 2024. The deal provides the med-tech giant a potentially game-changing entree into the lucrative left atrial appendage (LAA) market.
Left atrial appendage (LAA) occlusion procedures are designed to reduce the risk of thromboembolism in patients who have non-valvular atrial fibrillation, but a study presented at the 2023 Transcatheter Cardiovascular Therapeutics annual meeting in San Francisco demonstrated that about half of patients continue to have LAA leaks – and potentially the risk of dangerous blood clots and stroke – a year after the procedure.