Biosense Webster Archives - Page 2 of 2

Biosense Webster begins Omnypulse pulsed-field ablation trial

Johnson & Johnson’s Biosense Webster today announced the first cases with its investigational Omnypulse catheter as part of the Omny-IRE clinical trial.

The Omnypulse platform features the Omnypulse catheter and the Trupulse generator. Omny-IRE looks at the platform for mapping and treatment of symptomatic paroxysmal AFib during standard ablation procedures.

Dr. Dr. Mattias Duytschaever performed the first procedures at AZ Sint-Jan Hospital in Brugge, Belgium. Omny-IRE, a pivotal, prospective, multi-center, non-randomized trial looks set to enroll approximately 135 patients. Taking place in Europe and Canada, it will evaluate Omnypulse’s safety and effectiveness.

“In the cases I performed as part of the Omny-IRE trial, the contact force data from the Omnypulse catheter aided the initial map creation in the Carto 3 system, and the integrated PF Index module allowed me to correlate my ablation parameters with the lesion creation,” said Duyt…

J&J used RWE for an expanded indication — and you can, too

Two J&J MedTech leaders shared advice to help medical device developers use real-world evidence (RWE) in FDA submissions.

J&J MedTech’s Biosense Webster ThermoCool SmartTouch [Image courtesy of J&J MedTech]

Real-world evidence (RWE) took a big step forward recently when the FDA approved an expanded indication for a Johnson & Johnson MedTech ablation catheter.

For the first time, the federal medical device safety regulator approved a label expansion based on RWE from a retrospective study of health records documenting off-label use by physicians.

“The clinical evidence used to support the expansion of indications was based solely on an analysis of a dataset comprised of electronic health records from two hospital systems,” the agency said. “The FDA worked closely with the study sponsor to ensure that the RWE resulting from the analysis was both relevant and reliable…

FDA approves multiple AFib ablation devices from Biosense Webster

The Thermocool SmartTouch SF ablation catheter [Image courtesy of J&J’s Biosense Webster]Johnson & Johnson’s (NYSE: JNJ) + Biosense Webster announced today that the FDA approved several products in its cardiac ablation portfolio for zero fluoroscopy workflow.

Products that received approval include the ThermoCool SmartTouch SF catheter, the most commonly used ablation catheter for radiofrequency ablation. The portfolio’s approved products also include the standard ThermoCool SmartTouch and Carto Vizigo bi-directional guiding sheath. Biosense Webster’s Pentaray Nav Eco high-density mapping catheter, DecaNav mapping catheters and the Webster CS catheter also picked up approval.

Updated workflows indicate that direct imaging guidance, like ultrasound, can offer an alternative to fluoroscopy.

“The label change approved by the FDA underscores that the Biosense Webster integrated eco…

J&J’s Biosense Webster launches AFib mapping catheter

The Optrell mapping cathter. [Image courtesy of Biosense Webster]Johnson & Johnson’s (NYSE: JNJ) + Biosense Webster announced today that it launched the Optrell mapping catheter with TrueRef technology.

Irvine, California-based Biosense Webster designed Optrell as a high-density diagnostic catheter powered by its Carto 3 system. It features small electrodes arranged in a fixed array formation. These provide high-definition electrophysiological mapping of complex cardiac arrhythmia cases.

Optrell with TrueRef maps cases like persistent AFib, redo AFib ablation, atrial tachycardia and ventricular tachycardia.

Biosense Webster received FDA 510(k) clearance for Optrell with TrueRef in 2022. In addition to this U.S. launch, it plans to make the technology available in Japan later this year.

Get the full story at our sister site, Medical Tubing & Extrusion.

J&J’s Biosense Webster gets a new president

Jasmina Brooks, Biosense Webster president [Image courtesy of LinkedIn]Johnson & Johnson’s Biosense Webster this week announced it appointed Jasmina Brooks as president.

As president, Brooks will be responsible for setting Biosense Webster’s global strategy and advancing its innovation agenda to position the company for continued growth.

Brooks succeeds Michael Bodner, who is now the global head of heart recovery for J&J MedTech. She has more than 25 years of experience in the cardiovascular field with a primary focus on electrophysiology.

Most recently, Brooks was the VP of global strategic marketing at Biosense Webster, where she worked with cross-functional and international teams to set the strategy and shape the company product pipeline to drive growth, market share and profitability. She previously joined the company in 2014 and has held numerous roles within the global strategic marketing organization at Biosense Webster.

“…

Data supports Biosense Webster RF ablation for treating AFib

The QDOT Micro catheter. [Image from Biosense Webster/Johnson & Johnson MedTech]Johnson & Johnson MedTech’s Biosense Webster today announced data from a study of its QDOT Micro catheter for treating AFib.

JACC: Clinical Electrophysiology published data from the Q-FFICIENCY study evaluating QDOT Micro’s safety and 12-month effectiveness. The study observed use of the catheter in paroxysmal AFib ablation using a combination of high-power and conventional modes. QDOT features a very high-power, short-duration QMODE+ mode and a conventional-power, temperature-controlled QMODE setting.

Irvine, California-based Biosense Webster conducted its prospective, multicenter study across 22 U.S. centers. It evaluated 166 patients with drug-refractory, symptomatic paroxysmal AFib. The study demonstrated that the use of QDOT’s QMODE+ setting, alone or inc combination with QMODE, improved procedural efficiency. It also showed enhanced 12-month effectivenes…

The biggest cardiology tech stories from ACC.23

Medtronic, Abbott, iRhythm and more presented new data at a major cardiology conference, ACC.23. [Images courtesy of Medtronic, Abbott and iRhythm] 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, cardiac implants, monitors and imaging technology represented a handful of the technologies on display. Medtronic, Abbott, Boston Scientific, Edwards and more offered new data on their innovative technologies in these areas.

Here are some of the biggest stories that came out of the cardiology conference.

Excitement builds around using pulsed-field ablation to treat AFib

Medtronic, Boston Scientific and Johnson & Johnson MedTech’s Biosense Webster all released new…

Biosense Webster marks first cases with dual energy ablation tech

The Thermocool SmartTouch SF ablation catheter [Image courtesy of J&J’s Biosense Webster]Biosense Webster today announced the first cases with its investigational Thermocool SmartTouch SF dual energy catheter for treating AFib.

The system enables doctors performing an ablation to toggle between two types of energy: pulsed-field and radiofrequency. It appears to be the Johnson & Johnson MedTech subsidiary’s answer to the dual energy ablation tech coming out of Affera, which competitor Medtronic acquired for $1 billion last year.

Dr. Tom De Potter performed the first procedure with Thermocool SmartTouch at OLV Hospital in Aalst, Belgium. Biosense Webster said Dr. Mattias Duytschaever of AZ Sint-Jan Brugge Oostende AV performed several additional cases. The Brugge, Belgium, hospital is also taking part in the clinical trial.

“While radiofrequency ablation has decades of safety and efficacy data to support it, pulse field ablation is a novel…

How Johnson & Johnson is looking to lead the way in ablation

“If you want to go fast, go alone. If you want to go forward, go together,” Johnson & Johnson’s Celine Martin (left) said of innovation during a DeviceTalks West 2022 keynote interview with MassDevice executive editor Chris Newmarker (right). [Image by Kara Singleton, WTWH Media]Celine Martin, Johnson & Johnson group chair, cardiovascular & specialty solutions (CSS) group, oversees high-growth areas at the company’s global MedTech business.

Her leadership covers Acclarent, Biosense Webster, Cerenovus and Mentor. Together, those companies bring in more than $5 billion in annual sales with more than 14,000 employees.

Over 25 years at Johnson & Johnson, Martin has looked to improve standards of care for AFib, stroke and minimally invasive surgery. At DeviceTalks West in Santa Clara last week, she spoke in a keynote address about how she’s done it.

On treating AFib at Biosense Webster

Martin said at DeviceTalks that…

Biosense Webster launches HelioStar in Europe

Biosense Webster today launched its HelioStar balloon ablation catheter in Europe.

Johnson & Johnson’s subsidiary Biosense Webster launched the radiofrequency balloon ablation catheter for catheter-based cardiac electrophysiological mapping of the atria when used with a multi-channel RF generator.

According to the company, more than 11 million people in Europe have AFib. The expectation is that by 2030, the number of people with the heart condition will increase by up to 70%. Catheter ablation is typically recommended as the first treatment option for the condition and has been associated with improved quality of life and significant reductions in AFib burden, Biosense Webster said in a news release.

Get the full story on our sister site, Medical Tubing + Extrusion.

J&J’s Biosense Webster launches mapping catheter for cardiac arrhythmias

[Image from Biosense Webster]Johnson & Johnson’s Biosense Webster announced today that it launched the Octaray mapping catheter with TRUEref technology.

Irvine, California-based Biosense Webster designed Octaray for mapping cardiac arrhythmias, including AFib. It is powered by the company’s Carto 3 Version 7 system.

Get the full story at our sister site, Medical Tubing & Extrusion.

18 of the world’s most innovative medical technologies

[Images courtesy of Sysmex, Abbott, Boston Scientific, Medtronic and Siemens Healthineers]Judges this week are voting for the most innovative medical technologies among the nominees for the 2022 Prix Galien International Awards.

The Prix Galien International Awards highlight the most innovative technologies in the life sciences industry. The New York-based Galien Foundation presents the international award to eligible nominees that have received a Prix Galien award within the last two years in the Best Biotechnology Product, Best Digital Health Solution, Best Medical Technology, Best Pharmaceutical Product and Best Vaccine categories.

The Prix Galien International Awards ceremony will be co-hosted with the Prix Galien U.K. Award ceremony on May 12 at the Natural History Museum in London.

Companies included in this year’s nominees range from large multinational corporations like Medtronic to smaller medtech companies like Devices4Care. Here are the 18 medica…