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Abbott's (ABT) MitraClip Device Shows Favorable Outcome

Abbott Laboratories, Inc. ABT recently presented late-breaking data from the Landmark COAPT trial for MitraClip, demonstrating the long-term benefits of the device in patients fighting heart failure. The data were presented at the American College of Cardiology's 72nd Annual Scientific Session together with the World Congress of Cardiology organized in New Orleans between March 4-6, 2023.

The recent development will fortify Abbott’s Structural Heart’s business.

Study Details

In the COAPT trial, symptomatic heart failure patients with severe secondary MR —  a condition in which a leaky valve caused by problems affecting other areas of the heart allows blood to flow back through the mitral valve — were evaluated with MitraClip plus guideline-directed medical therapy or guideline-directed medical therapy alone.

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The five-year results from the landmark COAPT trial demonstrated that MitraClip is safe, effective and can reduce hospitalizations while improving survival for heart failure patients with severe secondary (or functional) MR.

Benefits of Favorable Results

With about two decades of clinical experience in transcatheter mitral repair, Abbott's MitraClip paved the way for advancement in supporting people with mitral regurgitation, offering an alternative to surgery for patients who often need treatment to survive.

These five-year COAPT results prove that MitraClip is safe and effective at treating secondary MR in advanced heart failure patients, minimizing hospitalizations and helping patients live longer.

Per Abbott’s management, these results indicate that MitraClip plays a vital role in enhancing the symptoms of people with this serious heart condition and getting them back to living their fullest lives.

Industry Prospects

Per a recent Allied Market Research market, the global structural heart devices market is expected to be worth $12.1 million by 2022, at a CAGR of 10.5%. Given the rising rate of cardiac ailments and the critical need to detect them, we believe Abbott is well-positioned to cash in on the opportunities in this market.

Recent Developments

This month, Abbott presented late-breaking data for the TriClip transcatheter edge-to-edge repair (TEER) system –a first-of-its-kind minimally invasive device developed specifically for tricuspid heart valve repair. The TRILUMINATE Pivotal study assesses the superiority of TriClip compared to medical therapy in treating patients with severe, symptomatic tricuspid regurgitation (TR) at intermediate or greater risk for open-heart surgery.

Last month, Abbott presented late-breaking data for its newest-generation Navitor transcatheter aortic valve implantation (TAVI) system. The study supported Navitor's recent FDA approval to treat people with severe, symptomatic aortic stenosis who are at high or greater risk for open-heart surgery. The company also demonstrated late-breaking data for the Amplatzer Amulet Left Atrial Appendage (LAA) Occluder that continue to reflect the benefits of this device's immediate and complete closure of the LAA – a differentiator from competing therapies – for patients with atrial fibrillation (AFib) at risk of stroke.

Developments Within Peers

A few other companies like Medtronic plc MDT, Edwards Lifesciences, Inc. EW and Boston Scientific, Inc. BSX are also progressing well within the Heart segment.

In February 2023, Medtronic announced the relaunch of its Harmony Transcatheter Pulmonary Valve (TPV) System – a minimally invasive alternative to open-heart surgery for congenital heart disease patients with native or surgically repaired right ventricular outflow tract (RVOT). Harmony TPV was designed to treat patients with RVOT anomalies who develop severe pulmonary valve regurgitation, a condition where blood leaks back into the right lower chamber of the heart after being pumped into the lungs.

In November 2022, Edwards Lifesciences presented one-year results on patients treated in the single-arm, prospective, global, multi-center TRISCEND study of the company’s EVOQUE transcatheter tricuspid valve replacement system which demonstrated favorable safety, efficacy and quality-of-life outcomes.  The one-year outcomes demonstrated high survival and high freedom from heart failure hospitalization.

In November 2022, Boston Scientific presented the first results from the ACURATE neo2 Post Market Clinical Follow-up (PMCF) study evaluating the performance of the ACURATE neo2 Aortic Valve System. These trial data confirmed the success of meaningful and differentiated enhancements included in the design of the ACURATE neo2 valve, from low rates of PVL and first-time pacemaker implantation to excellent hemodynamic performance and high rates of procedural success and safety.

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