Medtronic announced that doctors completed the first commercial case in the U.S. with its Symplicity Spyral renal denervation (RDN) system. Also known as the Symplicity blood pressure procedure, Symplicity Spyral treats high blood pressure, or hypertension. The first procedure follows the landmark approval for the system earlier this month. Approval made Medtronic the second company […]
Catheters
What’s next for Medtronic’s RDN program after FDA approval?
Medtronic is planning its first commercial renal denervation (RDN) cases and is already running a postmarket study after winning FDA approval of its Symplicity Spyral system for hypertension. In an interview before the Thanksgiving break, Medtronic SVP Jason Weidman — who’s also president of the company’s coronary and RDN business — said he expects the […]
Medtronic pulsed-field ablation system wins CE mark
Medtronic said today that it’s received a CE mark for its PulseSelect pulsed field ablation system. In addition, the medtech giant received European Union approval for its Nitron CryoConsole, which builds upon the legacy of the company’s cryo franchise with features to optimize the workflow for cryoballoon ablation. The news of the regulatory wins in […]
Neptune Medical brings on Intuitive co-founder as its board chair
Neptune Medical, the parent company of Triton Medical Robotics, has appointed a new board chair — and he’s well-known in surgical robotics. Dr. Fred Moll co-founded surgical robotics pioneer Intuitive in 1995. In recent years, he led robotic surgery developer Auris Health to its $3.4 billion sale to Johnson & Johnson in 2019. He’s presently […]
FDA approves Medtronic’s Symplicity Spyral renal denervation system
Medtronic today announced FDA approval of its Symplicity Spyral renal denervation (RDN) system for treating hypertension. [Update: Read more of our coverage from the weeks following the approval, including Medtronic’s lessons learned, what’s next for the technology, and other potential applications.] A Medtronic spokesperson said the device developer received word from regulators Friday evening. Medtronic […]
Boston Scientific has more positive Farapulse pulsed-field ablation data
Researchers shared positive data from a large, real-world registry of patients treated with the Boston Scientific Farapulse system. Data from more than 17,000 patients in the MANIFEST 17K registry reinforced the real-world safety profile for the pulsed-field ablation (PFA) system. Results included no reports of permanent phrenic nerve palsy, pulmonary vein stenosis or esophageal injury. […]
Acutus Medical is laying off more than half of its workers
Acutus Medical (Nasdaq:AFIB) announced today that it will lay off 65% of its workforce as part of a major restructuring. The Carlsbad, California–based company’s most recent annual report lists 225 workers at the end of 2022, which means the layoff could involve roughly 146 workers. Restructuring will involve winding down Acutus Medical’s EP mapping and […]
ICU Medical stock falls on Q3 revenue miss
ICU Medical stock is down today after a third-quarter earnings report that included a revenue miss. ICUI shares were down more than 15% to $86.68 apiece by midday trading today. MassDevice‘s MedTech 100 Index was down slightly. San Clemente, California–based ICU Medical — maker of infusion systems, infusion consumables and critical care products — announced […]
Cordis has a new CEO
About two months after former Spectranetics CEO Scott Drake became executive board chair at Cordis, he’s moved into the corner office at the cardiology and endovascular devices company. Drake replaces Shar Matin, who has stepped down as CEO, the company announced yesterday. Hunter Philbrick, Hellman & Friedman partner and company board member, noted in a […]
Biosense Webster has positive data for QDOT Micro ablation catheter
Johnson & Johnson MedTech’s Biosense Webster today announced new findings supporting the use of its QDOT Micro catheter. Published in the Journal of Cardiovascular Electrophysiology, the results demonstrate improved AFib control. They also showed relief of symptoms and overall quality of life improvements with QDOT Micro ablation treatment. The QDOT Micro catheter, a next-generation radiofrequency (RF) […]
Inari Medical plans to buy LimFlow Medical for up to $415M
Inari Medical today announced a definitive agreement to purchase LimFlow Medical for up to $415 million. The deal comes just weeks after Paris-based LimFlow won FDA premarket approval (PMA) for its breakthrough system to treat chronic limb-threatening ischemia (CLTI). San Jose, California–based Inari said it expects to complete the acquisition by the end of 2023. […]