MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » Medtronic launches IDE trial for AFib tech

Medtronic launches IDE trial for AFib tech

By

Medtronic logo updatedMedtronic (NYSE:MDT) announced today that it conducted the first procedures of its Pulsed AF AFib treatment pivotal trial.

The investigational device exemption (IDE) trial is evaluating the PulseSelect pulsed field ablation (PFA) system that uses pulsed electric fields to treat atrial fibrillation. The FDA granted the company approval to move forward with the IDE trial to evaluate the safety and effectiveness of the PulseSelect in January 2020.

Fridley, Minn.-based Medtronic’s platform uses the electric fields to ablate or create lesions and scar tissue, interrupting irregular electrical pathways in the heart and the triggers of AFib. Unlike traditional methods, PFA treatment is non-thermal and selectively targets cardiomyocytes (heart muscle cells) while avoiding other types of tissue.

According to a news release, Dr. Nitesh Sood performed the first procedure in the trial at Southcoast Health in Fall River, Mass. Dr. Arnoldas Giedrimas performed the second procedure at the same location.

Pulsed AF is a prospective, non-randomized, multi-center clinical trial set to enroll up to 500 patients to be treated with PulseSelect across as many as 50 sites in the U.S., Canada, Europe and Australia. Patients with a history of drug-refractory, recurrent and symptomatic paroxysmal or persistent AFib will be assessed at six and 12 months.

Results from the Pulsed AF pilot study were presented at Heart Rhythm Society 2020 Science with additional evidence shared at the AF Symposium earlier this year revealing 100% acute efficacy and no device or procedural-related events in the pilot cohort of patients treated with PulseSelect.

“For years, Medtronic has been an active leader in the investigation of the safety and efficacy of pulsed-field ablation,” Dr. Rob Kowal, CMO of Medtronic’s cardiac ablation solutions business, said in the release. “Developed internally at Medtronic, the PulseSelect system has the potential to create a paradigm shift in how cardiac ablations are performed for patients suffering from atrial fibrillation.”

In case you missed it

RSS From Medical Design & Outsourcing

  • DeviceTalks Boston 2022: Here’s what you missed on the show floor
    At DeviceTalks Boston 2022, there was a wealth of expertise to be had from exhibitors including Viant, ICS, PSN Labs, Propel and more. From stories of overcoming challenges during the COVID-19 pandemic to medical device materials pitfalls to avoid, MassDevice and MDO executive editor Chris Newmarker hit the DeviceTalks Boston show floor to discover insights. […]
  • Supply Chain EVP Greg Smith sees fewer suppliers in Medtronic’s future
    All eyes are on Medtronic’s global operations and supply chain leader as he works to modernize its operations and scrutinize suppliers. EVP of Global Operations and Supply Chain Greg Smith anticipates fewer suppliers in Medtronic’s future, he said in an interview this week. Smith spoke with DeviceTalks Editorial Director Tom Salemi in his first published… […]
  • CeQur is launching a discreet, convenient ‘wearable insulin pen’
    CeQur designed its Simplicity device to make insulin delivery as seamless as possible for people with diabetes. When it comes to managing diabetes, CeQur wants to make insulin therapy as convenient as possible. For those who prefer to manage their own insulin delivery, the Simplicity device might just do exactly that. Simplicity, a wearable, disposable… […]
  • Meddux opens new facility in Colorado
    Engineering, design, development and manufacturing company Meddux announced that it opened a new facility in Boulder, Colorado. The new, 22,000-square-foot facility doubles the overall square footage from its previous location in Colorado. According to a news release, it helps the company to quadruple its product development area and double its manufacturing footprint. Meddux’s new facility… […]
  • Reducing the Overall Cost of Validation
    By PTI Engineered Plastics Reliable medical devices and equipment are essential for researchers and doctors to accurately diagnose and treat a wide range of diseases. That is why there is such stringent oversight from the FDA to ensure these products meet the necessary requirements and specifications. To ensure compliance with regulators, manufacturers follow installation qualification… […]
  • BBS Automation has a deal to buy medtech supplier Kahle Automation
    BBS Automation said it plans to purchase high-speed automation supplier Kahle Automation to expand its medtech and life sciences business. Kahle will operate as Kahle – a BBS Company, according to a news release from Munich, Germany-based BBS and Lombardy, Italy-based Kahle. The deal is subject to regulatory approval. Terms were not disclosed. Kahle’s co-owners —… […]
  • How safe is health information after the overturning of Roe?
    The U.S. Department of Health and Human Services today issued guidance meant to better protect women’s health information as state abortion bans kick in after the U.S. Supreme Court’s overturning of Roe v. Wade. Despite the HHS actions, women may still wonder whether their health information is entirely safe going forward — a potential challenge… […]
  • Dexcom focuses on early diabetes diagnosis as COVID links emerge
    New evidence is showing that COVID-19 may increase a person’s risk of diabetes, but it could be years until we know for sure. In the meantime, Dexcom (Nasdaq:DXCM) is getting ready, VP of Global Clinical Initiatives Tomas Walker said. Walker recently spoke with Medical Design & Outsourcing to discuss the San Diego-based diabetes device developer’s… […]
  • Blackrock Neurotech and Pitt work on first at-home BCI system for remote trials
    Blackrock Neurotech and the University of Pittsburgh’s Rehab Neural Engineering Labs (Pitt RNEL) are working together on the first portable brain-computer interface (BCI) to allow patients to participate in research trials from home. A Blackrock representative said it’s the final step as the company prepares to launch its first commercial product early next year. Salt… […]
  • How medical device companies are responding to abortion bans
    Days after the U.S. Supreme Court’s decision to overturn Roe v. Wade’s protection of abortion rights, medical device companies are among those reassuring workers about healthcare access. Corporate communications to employees and the public at large come as trigger laws in nearly half of the states outlaw abortion immediately. Some medtech companies are not using… […]
  • Philips updates on testing results for recalled ventilators
    Royal Philips (NYSE:PHG) says only a small portion of returned respiratory devices displayed the sound abatement foam degradation that sparked a massive recall. Repeated ozone cleaning may have made the problem worse. Those were some of the major takeaways from an update Philips provided today on a comprehensive test and research program it implemented after its… […]