Medtronic expands cardiac portfolio
Medtronic won FDA clearance to expand its OmniaSecure defibrillation lead to the left bundle branch area and struck a distribution deal with Merit Medical for the ViaVerte basivertebral nerve ablation system — moves that broaden its cardiac rhythm and pain device offerings. The actions underscore Medtronic’s use of approvals and partner distribution to accelerate procedure‑level adoption. (simplywall.st)
FDA granted the OmniaSecure expanded indication on March 23, 2026, and the lead’s specification sheet lists it as a 4.7 French diameter, lumenless defibrillation lead approved for use in patients aged 12 and up. ( prnewswire.com ) Support for the approval came from the global LEADR LBBAP trial (NCT04863664), which enrolled 323 subjects and reported 100% defibrillation success at implant alongside a 2.1% OmniaSecure‑related major complication rate at three months. ( prismnews.com ) Medtronic first commercialized OmniaSecure in January 2026 and engineers the device on the footprint of its SelectSecure Model 3830 pacing lead while enabling combined approaches such as left bundle branch‑optimized CRT (LOT‑CRT) with either ICD or CRT‑D systems. ( medicaldevice-network.com ) ( prnewswire.com ) Medtronic’s distribution pact for Merit Medical’s ViaVerte specifies the system will be available later in 2026 as an implant‑free basivertebral nerve ablation (BVNA) option designed for same‑day outpatient treatment via a physician‑controlled steerable mechanism. ( news.medtronic.com ) The agreement expands an existing supplier relationship—Merit already provides Medtronic’s Kyphon Xpander inflation syringes and the KyphoFlex unipedicular steerable balloon catheter—positioning ViaVerte as an added option inside Medtronic’s neuroscience/pain portfolio under an exclusive distribution framework. ( prnewswire.com ) Medtronic framed the ViaVerte deal as a portfolio play to “expand our world‑leading pain interventions,” while Merit executives highlighted the company’s proprietary articulating technology as the rationale for the partnership. ( news.medtronic.com ) Analysts tracking cardiac rhythm management note Medtronic leads the CRMD market by 2025 revenue and the company’s OmniaSecure approval ties into a CRMD market projected to grow from about $10.7 billion in 2025 toward roughly $16 billion by 2035, reinforcing the commercial rationale for pushing conduction system pacing technologies. ( medicaldevice-network.com )
