Boston Scientific (BSX) mCRM System Study Outcome Favorable

Boston Scientific Corporation BSX recently presented favorable six-month results from the ongoing pivotal MODULAR ATP clinical trial of the mCRM System — the first modular cardiac rhythm management system that consists of the EMBLEM Subcutaneous Implantable Defibrillator or S-ICD System and the EMPOWER Leadless Pacemaker. The findings were concurrently published in the New England Journal of Medicine and presented at the Heart Rhythm Society's annual meeting, Heart Rhythm 2024.

The recent development will likely bolster Boston Scientific’s Cardiovascular business.

About mCRM System

The device is designed to communicate wirelessly to coordinate painless intracardiac anti-tachycardia pacing (ATP) therapy, provide rate-responsive bradycardia pacing support and prevent sudden cardiac death without the use of leads in the heart or under the sternum.

The company anticipates FDA approval of the mCRM System in 2025.

Study Details

The trial assessed not only the safety and functionality of the EMPOWER LP as a stand-alone pacemaker but also the efficacy of the EMBLEM S-ICD System in wirelessly requesting the LP to administer ATP treatment. The trial's results satisfied all predetermined six-month safety and efficacy criteria.

The trial's results met all pre-established six-month safety and effectiveness endpoints. They showed that the EMPOWER Leadless Pacemaker was implanted with a major complication-free rate of 97.5%, that communication between the EMBLEM S-ICD System and the EMPOWER Leadless Pacemaker was successful in 98.8% of cases, that anti-tachycardia pacing was successful in 61.3% of cases and that no patient requested that anti-tachycardia pacing or bradycardia pacing be turned off because of pain or discomfort.

Study Outcome Benefits

Boston Scientific observed outstanding overall clinical performance of the mCRM System in this trial, including a high rate of successful communication from the S-ICD to the leadless pacemaker and a low rate of serious leadless pacemaker problems. These findings are significant because the high percentages of communication success and pain-free termination of spontaneous arrhythmia episodes suggest a potential upgrade pathway for patients currently implanted with an S-ICD who require ATP or pacing.

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Instead of exposing all patients to the risks of more invasive approaches, such as placing leads into the heart or tunneling them under the sternum to provide therapies they may not need, these findings suggest physicians may be able to tailor therapy to the patient's specific needs and health.

Industry Prospects

Per a report by Grand View Research, the global cardiac rhythm management devices market size was estimated at $16.43 billion in 2023 and is expected to register a CAGR of 6.3% from 2024 to 2030. The growing prevalence of various cardiovascular diseases, such as arrhythmia and atrial fibrillation, among others.

Other Notable Highlights

In February 2024, Boston Scientific gained the FDA’s approval for the FARAPULSE Pulsed Field Ablation (PFA) system, which is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) atrial fibrillation. The system represents a unique new alternative to standard-of-care thermal ablation treatment.

Earlier in 2023, Boston Scientific completed enrollment in the first phase of the ADVANTAGE AF clinical trial, which is studying the FARAPULSE PFA system for treating patients with drug-refractory, symptomatic, persistent AF. The company also commenced enrollment in a second phase of the study to evaluate the safety and effectiveness of the adjunctive use of the FARAPOINT PFA Catheter for cavotricuspid isthmus ablations — a procedure used to treat atrial flutter.

Price Performance

In the past year, Boston Scientific shares have appreciated 39.1% compared with the industry’s rise of 1%.

Zacks Rank and Other Key Picks

Boston Scientific currently carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks from the broader medical space are Medpace MEDP, ResMed RMD and Encompass Health Corporation EHC.

Medpace, sporting a Zacks Rank #1 (Strong Buy), reported first-quarter 2024 earnings per share (EPS) of $3.20. The figure beat the Zacks Consensus Estimate by 30.6%. Revenues of $511 million improved 17.7% from last year’s comparable figure. You can see the complete list of today’s Zacks #1 Rank stocks here.

Medpace has an estimated 2024 earnings growth rate of 26.5% compared with the industry’s 12.3%. The company’s earnings surpassed estimates in each of the trailing four quarters, the average being 12.8%.

ResMed, sporting a Zacks Rank #2, reported a first-quarter 2024 EPS of $2.13, which topped the Zacks Consensus Estimate by 10.9%. Revenues of $1.20 billion surpassed the Zacks Consensus Estimate by 1.9%.

RMD has an estimated fiscal 2024 earnings growth rate of 17.9% compared with the industry’s 15.7%. In each of the trailing four quarters, the company delivered an average earnings surprise of 2.8%.

Encompass Health, carrying a Zacks Rank #2, reported first-quarter 2024 adjusted EPS of $1.12, surpassing the Zacks Consensus Estimate by 20.4%. Net operating revenues of $1.3 billion topped the Zacks Consensus Estimate by 3.6%.

EHC has an estimated long-term earnings growth rate of 15.6% compared with the industry’s 11.7% growth. The company’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 18.7%.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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