MedTech News Briefs | September 25th, 2023

Monday September 18th

Johnson & Johnson’s Biosense Webster has initiated the Omny-IRE clinical trial, using its investigational Omnypulse catheter platform for mapping and treating symptomatic paroxysmal atrial fibrillation (AFib) during standard ablation procedures. The trial, taking place in Europe and Canada, will assess the safety and effectiveness of the Omnypulse platform, which combines a large ablation area, high-density mapping capabilities, and pulsed-field ablation to potentially reduce the risk of damage to surrounding tissues during AFib treatment.
The FDA has updated its guidance on the Breakthrough Devices Program, explicitly mentioning the importance of accessibility in evaluating whether a new medical technology is more effective. The update reflects the FDA’s commitment to health equity and considers technologies and device features that improve accessibility when assessing a device’s potential for more effective treatment or diagnosis.
Dassault Systèmes has introduced an ‘Emma’ avatar as part of its digital twin technology to promote awareness of health research. This ‘Emma Twin’ uses anonymous health data to conduct numerous tests aimed at gaining insights into various diseases and therapies, showcasing its participation in ongoing research trials and medical innovations through a LinkedIn page.

Tuesday September 19th

Researchers at ETH Zurich have developed a novel insulin delivery system triggered by music, specifically the song “We Will Rock You” by Queen. The system uses genetically modified insulin-producing cells that respond to sound waves by releasing insulin, potentially offering a unique and less invasive approach to diabetes treatment.
Accumold has developed a novel method for high-volume micro injection molding of thin-wall cannulas. This technology offers medical device manufacturers a more efficient and cost-effective solution for producing these intricate components, with potential applications in minimally invasive procedures and innovative medical devices.
Johnson & Johnson’s Biosense Webster subsidiary has initiated clinical development of its Omnypulse catheter, designed for use in pulmonary vein isolation (PVI) procedures. The catheter features contact force feedback, and J&J aims to evaluate its performance in PVI procedures through a non-randomized study involving 135 patients in Europe and Canada.

Wednesday September 20th

BostonGene is partnering with Hokkaido University Hospital to use AI-based molecular tests to identify the best therapy options for HER-2 low breast cancer patients. The collaboration aims to better understand various approaches to treating breast cancer and will utilize BostonGene’s AI technology to analyze tumor microenvironments and HER2 expression levels in certain patients, helping to determine the efficacy of trastuzumab-deruxtecan, an antibody-drug conjugate targeting HER2.
Stryker has launched the PROstep MIS Lapidus fixation system, a minimally invasive surgical solution for treating bunions. The system offers advantages such as reduced recurrence rates, decreased scar size, and lower opioid usage compared to traditional open Lapidus procedures, according to the company.
Abbott Laboratories and WeightWatchers have launched a connected app that allows users following the WW Diabetes-Tailored Plan to access their glucose data from Abbott’s FreeStyle Libre 2 continuous glucose monitoring system within the WW app. The partnership aims to help people living with diabetes better understand how food and activity impact their glucose levels and make healthier lifestyle choices.

Thursday September 21st

The FDA has approved LimFlow’s LimFlow System for Transcatheter Arterialization of Deep Veins (TADV) to treat chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease. This minimally invasive procedure diverts blood around diseased arteries and into veins to restore blood flow into a patient’s ischemic foot, offering a new option for patients who have no other suitable endovascular or surgical treatment options available to avoid amputation.
Medtronic has received CE mark approval for its Simplera continuous glucose monitor (CGM), which offers a two-step insertion process and eliminates the need for overtape, simplifying diabetes management for individuals who use multiple daily injections (MDI). The device can integrate with the InPen smart insulin pen for real-time, personalized dosing guidance.
i-Cardia has completed patient enrollment for the pivotal study of its ShortCut device, designed to split the leaflets of pre-existing valves to facilitate safe transcatheter aortic valve replacement (TAVR) in patients at risk of coronary obstruction. The study, conducted at 20 TAVR centers in Europe and the US, involved 60 subjects undergoing valve-in-valve procedures, and the results will pave the way for ShortCut’s commercialization in the US and Europe, potentially by 2024.

Friday September 22nd

Boston Scientific is set to acquire Relievant Medsystems and its Intracept system, a minimally invasive treatment for chronic low back pain. The transaction, expected to close in the first half of 2024, includes an $850 million upfront cash payment, with additional contingent payments contingent on sales performance over the next three years.
Boston Scientific is anticipating strong growth in the cardiovascular disease markets of PFA (pulsed field ablation) and LAAC (left atrial appendage closure). The company expects rapid adoption of its Farapulse technology in the PFA market and foresees its Watchman LAAC device continuing to grow, with the potential to quadruple the number of eligible patients by 2030 through new indications and expanded reimbursement.
Realeve has secured a grant to conduct a study at the Cleveland Clinic using its Pulsante micro-neuromodulation system to potentially improve blood circulation in stroke patients and optimize neurological recovery. Pulsante is an externally powered implantable neuromodulation device that stimulates the sphenopalatine ganglion (SPG) and has the potential to address various central nervous system disorders such as tumors and Alzheimer’s by influencing the blood-brain barrier.

Sources

ThinkMedTek