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May 2, 2022

Abbott reports results from study of TactiCath SE for atrial fibrillation

The trial data showed that patients reported significant quality-of-life improvements.

Abbott has announced results from the PERSIST-END study of its TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) for persistent atrial fibrillation (AFib), the most common arrhythmia.

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The prospective, multi-centre, single-arm clinical trial showed that nearly nine out of ten patients (89%) treated for AFib with the company’s TactiCath SE remained symptom-free for up to 15 months after the procedure.

Additionally, the data showed that patients reported significant quality-of-life improvements and over 50% reduction in the use of health care resources, due to the therapy.

Abbott electrophysiology business chief medical officer Christopher Piorkowski said: “Ablation therapy is an increasingly important option for people living with cardiac arrhythmias because it allows physicians to treat the cause of the arrhythmia at its source.

“We developed TactiCath SE to provide clear information on whether the device is making contact with the heart wall and whether the pressure is enough to achieve the therapeutic goals.

“The outcomes are clear – the system delivers safe and effective results.”

TactiCath SE is used as part of a minimally invasive cardiac ablation procedure and in conjunction with Abbott ‘s EnSite X EP System, the Advisor HD Grid Mapping catheter, and EnSite Omnipolar Technology (OT).

Carried out from 2018 to 2021, the PERSIST-END trial included 224 patients recruited from 21 investigational sites in the US and Australia.

In the trial, subjects were evaluated for 15 months following the cardiac ablation procedure for safety, efficacy, and quality of life measures.

All of the primary safety, effectiveness and quality of life endpoints were met in the trial.

Additionally, as per the overall primary effectiveness endpoint, 61.6% of subjects remained free from any new or increased Class I/III AAD, arrhythmia recurrence, repeat ablation or cardioversion.

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GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
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