Abbott today announced new, late-breaking data from the global Leadless II IDE study evaluating Abbott's investigational Aveir leadless pacemaker in patients with certain abnormal heart rhythms. The data shows the Aveir device met its pre-specified primary endpoints and suggest that the Aveir system, once approved, could offer new benefits for patients who require the use of a pacemaker to treat slow heart rhythms. ...

Abbott (NYSE: ABT) today announced new, late-breaking data from the global Leadless II IDE study evaluating Abbott's investigational Aveir leadless pacemaker in patients with certain abnormal heart rhythms. The data shows the Aveir device met its pre-specified primary endpoints and suggest that the Aveir system, once approved, could offer new benefits for patients who require the use of a pacemaker to treat slow heart rhythms.

The findings were presented today in a late-breaking session at the annual Scientific Sessions of the Asia Pacific Heart Rhythm Society (APHRS) and simultaneously published in the Journal of the American College of Cardiology: Clinical Electrophysiology . The data from the study has also been submitted to the U.S. Food & Drug Administration as the Aveir leadless pacemaker is evaluated for U.S. approval.

People who experience slower-than-normal heart rates may receive a pacemaker to restore a more normal heart rate. Yet unlike traditional pacemakers, leadless pacemakers do not require an incision in the chest to implant the device or insulated wires – known as cardiac leads – to deliver energy to the heart. Instead, leadless pacemakers are implanted directly into the heart's right ventricle via a minimally invasive procedure, requiring no cardiac leads to deliver therapy.

"The new Aveir pacing system holds the potential to help us advance treatment for patients who need a pacemaker but where physicians are concerned about more invasive surgery or in circumstances where we believe a patient's therapy needs may change in the future and where retrievability will be a critical device feature," said Dr. Vivek Y. Reddy , Helmsley Trust professor of medicine, director of cardiac arrhythmia services, Mount Sinai Hospital.

Under the Leadless II trial design, primary safety and efficacy endpoints were analyzed in the 200 patients enrolled in 43 centers in the U.S., Canada and Europe . Patients were followed for six weeks. Results of the study showed:

  • Successful implant of the Aveir leadless pacemaker in 98% of patients.
  • At six weeks post-implant, 96% of patients met the safety endpoint of no serious adverse device effects and 95.9% achieved the efficacy endpoint of acceptable therapy delivered to the patient (known as therapeutic pacing threshold and sensing amplitude).
  • Additionally, physicians were able to accurately position the device either the first time or with a single repositioning in 96% of clinical cases.

"As we developed the Aveir leadless pacemaker platform, our fundamental guiding principle was to design a device with extended battery life that could be retrievable, expandable to incorporate future innovation and provide improved patient outcomes with a minimally-invasive implant procedure," said Randel Woodgrift , senior vice president, Cardiac Rhythm Management, Abbott. "The results of the Leadless II study are a strong indicator that once the device is approved, the Aveir system can help physicians manage the care of patients with certain abnormal heart rhythms."

ABOUT THE LEADLESS II STUDY

The Leadless II IDE study is a prospective, non-randomized, multicenter study designed to evaluate the clinical safety and efficacy of the Aveir leadless pacemaker in patients who were indicated for a VVI(R) – or ventricular demand pacing – pacemaker, which stimulates the heart only if the heart rate falls below a set level.

For the primary endpoint analyses, all patients were followed for six weeks post-implant to evaluate potentially serious adverse device effects. During this time, efficacy was measured as acceptable pacing capture threshold (≤ 2.0 V at 0.4 msec) and sensing amplitude (R wave ≥ 5.0 mV, or a value equal to or greater than the value at implantation).

The Aveir leadless pacemaker system is being investigated as part of the Leadless II IDE – a global study – and is not yet commercially available. The device design specifications are subject to change pending regulatory review.

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews .

Cision View original content: https://www.prnewswire.com/news-releases/abbotts-new-leadless-pacemaker-system-meets-primary-endpoints-in-pivotal-trial-301423053.html

SOURCE Abbott

News Provided by PR Newswire via QuoteMedia

IDBS Polar Insight Brings Advanced Data Analytics and Visualization to BioPharma Lifecycle Management

IDBS, a Danaher (NYSE:DHR) operating company, announced Polar Insight, bringing new advanced data analytics and visualization tools to the Polar BioPharma Lifecycle Management (BPLM) platform.

Extracting valuable insights from process and quality data across the biopharmaceutical lifecycle is a time consuming and error prone process, requiring laborious manual work and multiple steps.

Keep reading... Show less

Medtronic receives Health Canada licence for GI Genius intelligent endoscopy module with artificial intelligence system for colonoscopy

Transformative AI System Enhances Colorectal Cancer Detection Capabilities

 Medtronic Canada ULC, a subsidiary of Medtronic plc (NYSE: MDT) — the global leader in medical technology — announced it has received a Health Canada licence for the GI Genius™ intelligent endoscopy module. GI Genius is a computer-aided detection (CADe) system that uses artificial intelligence (AI) to highlight regions of the colon suspected to have visual characteristics consistent with different types of mucosal abnormalities.

Keep reading... Show less
Beyond Medical Technologies Ramps Up COVID Mask Manufacturing in Response to New South Africa COVID Variant

Beyond Medical Technologies Ramps Up COVID Mask Manufacturing in Response to New South Africa COVID Variant

Beyond Medical Technologies Inc. (CSE: DOCT) (FSE: 7FM4) ("Beyond Medical" or the "Company") is pleased to provide the following corporate update regarding its wholly-owned subsidiary Micron Technologies Inc. ("Micron Technologies").

Keep reading... Show less
Leveljump Q3 Earnings and Results; Record Quarterly Revenues

Leveljump Q3 Earnings and Results; Record Quarterly Revenues

LevelJump Healthcare Corp. (TSXV: JUMP) (OTCQB: JMPHF) (FSE: 75J) ("Leveljump" or the "Company"), a Canadian leader in B2B telehealth solutions, is pleased to announce today it has reported financial results for the third fiscal quarter ended September 30th, 2021. All amounts are expressed in Canadian dollars.

Financial and Operational Highlights

Keep reading... Show less

Thermo Fisher Scientific Confirms Detection of SARS-CoV-2 in Samples Containing the Omicron Variant with its TaqPath COVID-19 Tests

- Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, today confirmed that its polymerase chain reaction (PCR) TaqPath COVID-19 Combo Kit *, and TaqPath COVID-19 CE-IVD RT-PCR Kit *, which test for the presence of SARS-CoV-2, are not impacted by the emerging B.1.1.529, or Omicron variant, enabling accurate test results.

The Omicron variant, which was designated a " variant of concern " by the World Health Organization (WHO), has more than 30 mutations in the spike protein alone. The WHO has reported that preliminary evidence suggests an increased risk of transmission compared to other variants of concern. This designation and information are leading to renewed travel restrictions and research to examine the variant's impact on efficacy of existing vaccines and tests. The WHO and European Centers for Disease Control have both reported that using S-gene target failure (SGTF) of the PCR assays as a proxy for the variant helped to identify Omicron. Cases of the variant were first identified in South Africa and have now been reported in at least a dozen countries around the world.

Keep reading... Show less
UPDATED - Leveljump Healthcare Corp. Announces 14.6% Minority Investment in Real Time Medical

UPDATED - Leveljump Healthcare Corp. Announces 14.6% Minority Investment in Real Time Medical

LevelJump Healthcare Corp. (TSXV: JUMP) (OTCQB: JMPHF) (FSE: 75J) ("Leveljump" or the "Company"), a Canadian leader in B2B telehealth solutions, is pleased to announce that, subject to regulatory approval, it has agreed to acquire an outstanding 14.6% minority equity interest in Real Time Medical Inc. ("RTM"), a private Ontario company, in exchange for 2,494,576 units (a "Unit") of Leveljump. Each Unit will be issued at a price of $0.66 per Unit with each Unit being comprised of three (3) Leveljump common shares at a deemed price of $0.22 per share and one (1) share purchase warrant of Leveljump, each warrant entitling the holder to acquire one additional common share of Leveljump at a price of $0.35 per common share on or before December 31, 2023.

The equity interest in RTM was acquired through a mini-tender offer to the shareholders of RTM dated November 1, 2021 whereby JUMP offered to acquire up to 19.9% of RTM in exchange for the Units. The holders of the RTM shares who have tendered are all accredited investors.

Keep reading... Show less

Top News

Related News