CereVasc announced today that it received FDA breakthrough device designation for its eShunt system for treating normal pressure hydrocephalus (NPH). The company said data generated during pilot clinical studies of the device supported the breakthrough device designation. This designation enables priority review and enhanced communication with … [Read more...] about CereVasc wins FDA breakthrough nod for eShunt system
Nitinol
Pulsed field ablation catheters take shape at Medtronic, Boston Scientific, Abbott and J&J’s Biosense Webster
Experts from Medtech Big 100 device developers — Medtronic, Johnson & Johnson MedTech, Abbott and Boston Scientific — discuss the various shapes of their pulsed field ablation (PFA) catheters. From flowers and loops to globes, baskets and balloons, there's no standard shape for the pulsed field ablation (PFA) catheters coming out of Medtronic, … [Read more...] about Pulsed field ablation catheters take shape at Medtronic, Boston Scientific, Abbott and J&J’s Biosense Webster
How Medtronic designed the PulseSelect pulsed field ablation system for AFib
Medtronic‘s PulseSelect became the first pulsed field ablation (PFA) system to win FDA approval for treating atrial fibrillation (AFib) in December 2023. The world’s largest medical device manufacturer achieved that milestone about 15 years after one of its engineers, Mark Stewart, coined the term “pulsed field ablation” in a research paper … [Read more...] about How Medtronic designed the PulseSelect pulsed field ablation system for AFib
This medtech developer is throwing everything at clots
Retriever Medical is developing a thrombectomy system with a four-front approach for treating blood clots. The Las Vegas-based startup calls its technology VORS AMD, for vascular occlusion removal system with aspiration, mechanical and drug delivery. The approach combines nitinol baskets for mechanical thrombectomy with aspiration, clot-busting … [Read more...] about This medtech developer is throwing everything at clots
First look: Medtronic’s Sphere-360 pulsed field ablation catheter design has some new tricks
The investigational Medtronic Sphere-360 pulsed field ablation and mapping catheter uses nitinol for a feature that's unique within Medtronic's PFA device portfolio.
Medtronic recently offered a first look at its Sphere-360 pulsed field ablation (PFA) and mapping catheter, an investigational device with some design features that are new for the world's largest device manufacturer.
In an interview with Medical Design & Outsourcing, Tim Laske, VP of research and business development for Medtronic Cardiac … [Read more...] about First look: Medtronic’s Sphere-360 pulsed field ablation catheter design has some new tricks The investigational Medtronic Sphere-360 pulsed field ablation and mapping catheter uses nitinol for a feature that's unique within Medtronic's PFA device portfolio.
Cook Medical signs distribution agreement with Bentley for BeBack catheter
Cook Medical today announced it signed a U.S. distribution agreement with Bentley for the BeBack catheter. Under the agreement, Cook Medical will assume commercial responsibilities for this Bentley product. “We are excited to welcome Bentley’s BeBack catheter to our peripheral intervention portfolio,” Alec Cerchiari, director of product … [Read more...] about Cook Medical signs distribution agreement with Bentley for BeBack catheter
ProVerum completes enrollment in ProVIDE clinical study for ProVee BPH treatment device
ProVerum this week announced it completed enrollment in its ProVIDE pivotal clinical trial to evaluate the safety and effectiveness of the ProVee system. The ProVIDE clinical trial is a prospective, multicenter, double-blind controlled study that evaluates the safety, performance, and effectiveness of the ProVee system in patients with lower … [Read more...] about ProVerum completes enrollment in ProVIDE clinical study for ProVee BPH treatment device
BD initiates IDE trial of stent for treating peripheral arterial disease
BD (NYSE: BDX) announced today that it enrolled the first patient in a trial of its Vascular Covered Stent for treating peripheral arterial disease (PAD). Franklin Lakes, New Jersey–based BD is evaluating the safety and effectiveness of the stent in its AGILITY FDA investigational device exemption (IDE) trial. The self-expanding, low-profile, … [Read more...] about BD initiates IDE trial of stent for treating peripheral arterial disease
New Synchron CTO Riki Banerjee on BCI manufacturing and outsourcing
After 12 years in Medtronic’s neuromodulation operating unit and two years as R&D VP at Synchron, Riki Banerjee is the brain-computer interface (BCI) developer’s new chief technology officer. More electrodes and thinner electrodes were always goals at Medtronic. But neuro device makers across the industry have faced the difficulties of … [Read more...] about New Synchron CTO Riki Banerjee on BCI manufacturing and outsourcing
Two-armed surgical robot prototype targets pediatric brain tumors
Researchers say they've developed a surgical robot for removing brain tumors in children, and that it could also offer a less invasive, safer option for adult neurosurgery and other procedures. The trick is using hollow, nitinol robot arms to allow neurosurgeons to swap tools during a tumor resection procedure, said Pierre DuPont. He's the chief … [Read more...] about Two-armed surgical robot prototype targets pediatric brain tumors
