Dublin-based Medtronic plc. has invested considerable resources into its renal denervation program, but the company has not completed its regulatory journey for the U.S. market just yet. Medtronic failed to persuade an FDA advisory committee of the virtues of its Symplicity Spyral device due to inconsistent results from the two major studies presented at the hearing but vowed to keep working on the application despite the sustained headwinds.
Safe Orthopaedics SAS reported results from a biomechanical study comparing its new surgical technique Sycamore – a pedicle-anchored implant – with standalone balloon kyphoplasty. The results published in summer 2023 in the Journal of Experimental Orthopaedics showed a “significant increase” in compression strength with patients using Sycamore.
Levita Magnetics International Corp. received uplifting news this week as the U.S. FDA cleared its magnetic-Assisted Robotic Surgery (MARS) minimally invasive surgical platform. MARS builds on the company’s first product, the Levita magnetic surgical system, by providing greater control of surgical instruments to surgeons. The platform is cleared for use in bariatric, colorectal, gallbladder and prostate surgeries.
The age of renal denervation as a treatment for hypertension may have finally arrived in the U.S. with the affirmative U.S. FDA advisory vote for the Paradise system for renal denervation by Recor Medical Inc., of Palo Alto, Calif. The 12-member advisory committee vote unanimously that the data suggested the ultrasound-based device was safe and voted 8-3 in support of the Paradise’s efficacy, an outcome that the agency may find difficult to refute, given the large public health impact of hypertension in the U.S.
Tandem Diabetes Care Inc. obtained reimbursement in France for its Control-IQ technology, an advanced hybrid closed loop system for patients with type 1 diabetes that uses an algorithm to automatically adjust insulin in response to predicted glucose levels.
Over the last six years, more than 20,000 patients have been implanted with the Sprint PNS system to manage acute or chronic pain, SPR Therapeutics Inc. reported. The 20,000th patient was treated for low back and leg pain with the Sprint Extensa XT system, which like the company’s other systems is implanted for 60 days in a minimally invasive surgery. The system uses percutaneous peripheral nerve stimulation (PNS) to recondition the central nervous system to provide long-term, significant relief from pain.
Taking a step forward in an increasingly crowded market that has long been dominated by non-Chinese players, Magassist Co. Ltd. got positive clinical results from its extracorporeal membrane oxygenation (ECMO) system Breathmo to provide support for patients with serious heart failure or lung failure, with a study showing that the system can provide pulmonary and cardiac support effectively and safely.
Neura Robotics GmbH closed a $55 million funding round that will allow the company to expand its operation into the U.S. and Japan and increase its production infrastructure in Germany amid growing demand. The company, which builds cognitive robots, has an order book which exceeds $450 million.
Endotheia Inc. reported the successful completion of a first-in-human clinical trial of its steerable technology for endoscopic surgery. The single-use device integrates with standard forward-viewing gastroscopes, allowing physicians to replicate the functions of specialized duodenoscopes that are currently used in the treatment of biliary disease.
Recalls are a fact of life in the medical technology space, and Medtronic plc and Quidel Cardiovascular Inc., have both been forced to report class I recalls. Dublin-based Medtronic announced a recall of more than 348,000 cardiac electrophysiology devices due to issues that could prevent high-voltage therapy while San Diego-based Quidel is recalling nearly 7,800 Triage cardiac panels because of a risk of false negatives for patients being assessed for an infarct.
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