Image Credit: Abbott
Abbott announced that it received FDA’s approval for the treatment of Parkinson’s, Essential Tremor, and some other movement disorders by stimulating the Internal Globus Pallidus (GPi) with its Infinity™ Deep Brain Stimulation (DBS) system.
This is the first approval by FDA using the Internal Globus Pallidus (GPi) as an alternative target to the subthalamic nucleus (STN) and ventral intermediate nucleus (VIM) for the treatment of these movement disorders.
Image Credit: Medtronic
Back in November 2019 Medtronic announced results from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study showing that an investigational set of algorithms in the Micra™ leadless pacemaker improves synchrony and cardiac function in patients with atrioventricular (AV) block. At the time, Medtronic submitted to FDA for approval of the Micra AV pacemaker, to expand the indicated population to AV block and normal sinus rhythm.
Medtronic announced this week that it received FDA’s approval for its Micra AV™ leadless pacemaker to treat AV block.
According to this week’s announcement:
“Micra AV is unique in the history of pacemakers. Until now, pacemakers sensed the heart’s electrical signals and used that information to provide pacing. But Medtronic scientists figured out how to re-purpose sensors, already inside the original Micra pacemaker, to recognize certain physical, or mechanical movements, within the heart – an approach to pacing that’s never been done before. Micra AV can detect the mechanical movement of a beat in one chamber of the heart – the atrium – and then pace another chamber where Micra is implanted – the ventricle – so the atrium and ventricle beat in synchrony.”
Image Credit: Zurich MedTech
The FDA announced the acceptance of Zurich MedTech’s Sim4Life IMAnalytics and the field exposure libraries MRIxVIP1.5T and MRIxViP3.0T from the IT’IS Foundation as a Medical Device Development tool (MDDT). This is the first FDA-approved computational modeling Medical Device Development Tool.
IMAnalytics is a software platform for the safety evaluation of implantable devices in the Magnetic Resonance (MR) environment. It characterizes RF-induced heating at the distal electrodes of implantable devices, using a variant of the Tier 3 approach as defined in ISO/TS 10974. It is tailored for elongated lead structures by making use of the transfer function method described in Annex K of the same technical specification.
Image Credit: Bioness
Bioness announced that its StimRouter received the CE-Mark to Treat Fecal Incontinence.
Unlike most externally-powered neurostimulators, the StimRouter is not powered by RF received from the external transmitter. Instead, the external pulse transmitter is more like a TENS unit with gelled electrodes applied to the skin. The implant has no electronic components. It is just a lead that has a coil electrode that intercepts part of the current between the TENS electrodes, and routes the captured current to small electrodes in contact with the target nerve at the distal end of the lead. Continue reading
Image Credit: Medtronic
Medtronic announced that it received the CE Mark for Percept™ PC neurostimulator. The Percept™ PC neurostimulator; is the only Deep Brain Stimulation (DBS) system to be launched in the European Union (EU) with BrainSense™ technology that can sense and record brain signals while delivering therapy to patients with neurologic disorders, such as Parkinson’s disease.
According to the press-release:
“BrainSense technology enables physicians to track patient-specific brain signals and correlate these with patient-recorded events, such as symptoms or side-effects associated with their disease or the medications to treat it. This enables more personalized, data-driven neurostimulation treatment. The Percept PC neurostimulator is approved in the EU for the treatment of symptoms associated with Parkinson’s disease (PD), essential tremor, primary dystonia as well as epilepsy and obsessive-compulsive disorder (OCD). It is currently under review by the U.S. Food and Drug Administration.
“DBS is proven to significantly improve motor function in people with Parkinson’s disease compared to standard medication alone – but with currently-available systems, physicians need to make therapeutic decisions mostly based on clinical assessments and patient-reported information,” said Professor Andrea Kühn, head of Movement Disorders and Neuromodulation, Charité University Hospital, Berlin. “Percept PC with BrainSense technology is a game changer. Patients and their care teams will have objective patient-specific brain signal data – including data recorded outside the clinic in patients’ everyday lives. With this technology, doctors could tailor therapy more precisely to the individual needs of each patient based on data from neuronal activity.” “