Biopharma · FDA Approvals · Stock
One of the largest medical-device companies, Medtronic develops and manufactures therapeutic medical devices for chronic diseases. Its portfolio includes pacemakers, defibrillators, transcatheter heart valves, stents, surgical robots, spinal fixation devices, neurovascular products, advanced energy, ablation laser ther…
Assets on file: Altaviva, AVIM Therapy, LigaSure RAS Maryland
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Medtronic Altaviva and Symplicity Spyral Receive Category I CPT Code Approvals
The AMA approved new Category I CPT codes for Altaviva implantable tibial neuromodulation and Symplicity Spyral renal denervation procedures. These permanent codes replace existing Category III codes and become effective in January 2028, supporting physician payment and informing commercial payer coverage decisions.
Orchestra BioMed exceeds enrollment in BACKBEAT pivotal trial of AVIM Therapy
Orchestra BioMed and Medtronic completed enrollment in the BACKBEAT global pivotal trial of AVIM Therapy with 330 randomized patients, exceeding the 316-patient target. Primary endpoint (3-month aSBP change) data will be submitted for late-breaking presentation at a major cardiovascular conference in Q2 2027. Positive results are expected to support subsequent marketing application submissions by Medtronic to the FDA and other regulators.
Medtronic: FDA clears LigaSure RAS Maryland on Hugo RAS system
The FDA cleared the LigaSure RAS Maryland jaw device for use with the Hugo RAS system in the U.S., expanding the robotic instrument portfolio. The clearance brings Medtronic’s vessel-sealing technology, already used in over 45 million procedures, into the U.S. robotic-assisted surgery workflow.
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