Medtronic said today that it's received a CE mark for its PulseSelect pulsed field ablation system. In addition, the medtech giant received European Union approval for its Nitron CryoConsole, which builds upon the legacy of the company's cryo franchise with features to optimize the workflow for cryoballoon ablation. The news of the regulatory … [Read more...] about Medtronic pulsed-field ablation system wins CE mark
Product Development
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
After recall and relaunch, Medtronic wants to go global with its catheter-delivered Harmony valve
Each Medtronic Harmony valve is sewn by hand to attach laser-cut pig tissue to the nitinol that makes this minimally invasive heart implant possible. Medtronic’s Harmony transcatheter pulmonary valve (TPV) design is paying off after engineers solved a delivery catheter recall and relaunched the system this year. The Harmony TPV uses pig tissue, … [Read more...] about After recall and relaunch, Medtronic wants to go global with its catheter-delivered Harmony valve
Medtronic wins CE mark for Affera ablation system
Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Affera mapping and ablation system. The Affera system includes the Sphere-9 catheter and Affera Prism-1 mapping software. Together, the system integrates Sphere-9 pulsed-field ablation (PFA), radiofrequency (RF) and high-density (HD) mapping. It maps and ablates … [Read more...] about Medtronic wins CE mark for Affera ablation system
The biggest cardiology tech stories from ACC.23
Major medtech players presented a range of intriguing studies at a gathering of some of the biggest names in the cardiology tech space. Some of the hottest topics were covered this past week at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology (ACC.23/WCC) in New Orleans. Ablation, … [Read more...] about The biggest cardiology tech stories from ACC.23
Medtronic pulsed-field ablation system exceeds safety goal in study
Medtronic (NYSE:MDT) announced today that its PulseSelect pulsed-field ablation (PFA) system exceeded its safety performance goal in a clinical trial. PulseSelect registered an adverse event rate of 0.7%. Medtronic said that marks one of the lowest adverse event rates of any previous FDA investigational device exemption (IDE) trial for AFib … [Read more...] about Medtronic pulsed-field ablation system exceeds safety goal in study
Alleviant Medical raises $75M for no-implant heart failure treatment
Alleviant Medical has raised $75 million to support a global pivotal trial of its catheter-delivered interatrial shunt to treat heart failure. The FDA provided the Austin, Texas–based company with an Investigational Device Exemption for the clinical trial in November 2022. Researchers have designed the ALLAY-HF study to demonstrate the safety … [Read more...] about Alleviant Medical raises $75M for no-implant heart failure treatment
The top 10 catheter innovation news stories of 2022
This year was a big one for catheter innovation as medtech companies large and small received regulatory approvals and researchers developed catheters that could soon make navigating the vasculature system easier. The numerous innovations weren't just limited to adults. One company launched a cryoablation catheter for children as young as 2 … [Read more...] about The top 10 catheter innovation news stories of 2022
The 24 best medical device innovations of 2022
The Galien Foundation recently announced its nominees of medical device innovations for its 2022 Prix Galien USA awards. There are 24 medical technologies nominated for the annual award this year, up from 18 nominees in 2021. The Galien Foundation’s annual Prix Galien awards highlight devices, biotechnology and pharmaceutical products … [Read more...] about The 24 best medical device innovations of 2022
Freudenberg Medical launches HelixTC bioprocessing overmolded silicone ends
Freudenberg today launched its HelixTC silicone overmolded sanitary ends for bioprocessing fluid transfer applications. HelixTC is based on Freudenberg's PharmaFocus Premium product line of platinum-cured silicone tubing. It is an alternative to standard barbed TC connections. The new overmolded sanitary ends are available in standard or mini … [Read more...] about Freudenberg Medical launches HelixTC bioprocessing overmolded silicone ends
