The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS commits more funds for testing, materials to fight pandemic; Medtronic announces recall of Valiant Navion; Florida man pleads guilty in DME fraud.
Medtronic plc said Monday that it has expanded its limited site release of its new radial artery access portfolio. Acquired from Rist Neurovascular Inc. last year, the portfolio includes the Rist 079 Radial Access guide catheter and Rist Radial Access selective catheter. Dublin-based Medtronic completed its acquisition of privately held Rist Neurovascular in August 2020 for an undisclosed sum – the eighth in a series of tuck-in deals the med-tech behemoth has undertaken since January 2020.
Medtronic plc received U.S. FDA premarket approval of its Diamondtemp Ablation (DTA) system for treatment of patients with recurrent, symptomatic paroxysmal atrial fibrillation. The temperature-controlled radiofrequency (RF) ablation system features industrial-grade diamonds, which provide 200 to 400 times the thermal conductivity seen in conventional ablation and enable more efficient delivery of energy to regions of the heart responsible for the erratic electrical signals underlying atrial fibrillation (AF).
Medtronic plc is looking to increase market share in pain stimulation with its differential target multiplexed (DTM) therapy, a recharge-free device and its next big disrupter, evoked compound action potential (ECAP). The company is currently developing a closed-loop SCS system for chronic pain following failed back surgery based on ECAP and DTM algorithms.
Medtronic plc reported that the first patient has been enrolled in the Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) study its trial evaluating the safety and efficacy of adaptive deep brain stimulation (aDBS) in patients with Parkinson's disease (PD). This type of stimulation is an investigational feature of the Percept PC device that could be enabled if approved.
Corrective and preventive action (CAPA) has a long and difficult history where med tech is concerned. Kathryn Merrill, the global quality/regulatory program director for Medtronic plc, of Dublin, said on a recent webinar that one of the main sources of uncertainty is that many in industry are not clear as to which circumstances dictate that a CAPA should be opened.
Sonivie Ltd. has won breakthrough device designation from the U.S. FDA for the Therapeutic Intra-Vascular Ultrasound (TIVUS) system for renal artery denervation (RDN) to treat resistant hypertension. At the same time, the company revealed that it has bought the remaining intellectual property and other assets related to the use of the TIVUS System from Cardiosonic Inc.
Critically ill infants in need of continuous renal replacement therapy (CRRT) are often treated using machines intended for adults, leading to a number of challenges and a high risk of complications and death. Now, Medtronic plc has launched a pediatric and neonatal acute dialysis machine in the U.S. that is specifically designed for patients weighing between 2.5 and 10 kilograms. The Carpediem Cardio-Renal Pediatric Dialysis Emergency Machine, the first of its kind in the U.S., received U.S. FDA clearance in April via the de novo pathway and is classified as a class II device.
Medtronic plc reported second quarter worldwide revenue of $7.647 billion, a decrease of 0.8% as reported and 1.5% on an organic basis. Analysts noted, however, that the figure beat the consensus of $7.08 billion. It also exceeded Wells Fargo’s $7.12 billion estimate. With the continued uncertainty related to the ongoing COVID-19 pandemic, the Dublin-based company did not provide formal annual or quarterly financial guidance. Still, the need for ventilators pushed the company ahead.
Medtronic plc's cryoablation could soon put drug therapy on ice in parts of the atrial fibrillation (AF) market, based on results of studies published in the New England Journal of Medicine (NEJM) and presented at the American Heart Association Scientific Sessions 2020.
