Yahoo Finance Boston Scientific's (BSX) POLARx System Gets FDA Approval
Boston Scientific Corporation BSX recently announced receiving FDA approval for its POLARx Cryoablation System. The POLARx FIT Cryoablation Balloon Catheter is a component of the new system intended to treat people with paroxysmal atrial fibrillation (AF). This catheter has the unusual ability to accommodate two balloon diameters, 28 and 31mm.
The latest approval is likely to bolster Boston Scientific’s Cardiovascular segment.
More on POLARx Cryoablation System
In February 2020, the POLARx Cryoablation System gained the CE Mark, and in October 2021, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) granted its certification. In 2023, the POLARx FIT catheter was given the go-ahead in Europe, Japan, Canada, and several Asia Pacific markets.
The latest system overcomes recognized drawbacks by rethinking current cryoablation options, enabling doctors to expand and modify the new POLARx catheter to match a patient's unique anatomy during an ablation treatment, which can reduce the need for time-consuming and disruptive device replacements. Additionally, the tool enables medical professionals to treat a more extensive variety of pulmonary vein anatomy and to design lesions in ideal locations to more effectively deliver therapy to the parts of the heart from which the disruptive impulses that cause AF originate.
Data from the global, prospective, non-randomized, single-arm FROZEN-AF IDE clinical trial, which was presented at Heart Rhythm 2023, showed that the POLARx Cryoablation System was safe and efficacious for the treatment of 385 patients with paroxysmal AF.
Significance of POLARx Cryoablation System
The expandable cryoballoon catheter in particular, part of the new POLARx Cryoablation System, is an exciting advancement for the successful treatment of AF since it enables medical professionals to better customise care for individual patients without compromising safety or effectiveness. As observed in the clinical evaluation, the system's maneuverability, combined with the ability to use different balloon sizes, allows it to address long-standing issues with various cardiac anatomy.
The FDA clearance of the POLARx Cryoablation System, which has been used for more than 25,000 patients globally, heralds a significant development in managing atrial fibrillation (AF) and the dawn of a new era in cryoablation technology. This product transforms a crucial therapy in the electrophysiology field, attends to the unmet needs of physicians, and reaffirms the company’s commitment to bringing significant advancements to existing technologies by prioritizing procedural flexibility and individualized care.
Industry Prospects
Per a report by Grand View Research, the global atrial fibrillation market size was valued at $22.4 billion in 2022 and is projected to grow at a CAGR of 10.1% by 2023. The increasing prevalence of atrial fibrillation (AFib) and growing awareness about the condition are expected to drive the market.
Peers Developments within Cardiac Segment
Within cardiac ablation treatment, companies like Johnson & Johnson JNJ, Abbott Laboratories ABT and Medtronic plc MDT are also making significant progress.
In August 2023, Biosense Webster, a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson received the FDA approval for multiple atrial fibrillation ablation products to be used in a workflow without fluoroscopy. The products that can be used in this workflow include: THERMOCOOL SMARTTOUCH SF catheter — the most commonly used ablation catheter in the world for RF ablation, THERMOCOOL SMARTTOUCH Catheter, CARTO VIZIGO Bi-Directional Guiding Sheath, PENTARAY NAV ECO High Density Mapping Catheter, DECANAV Mapping Catheters, and Webster CS Catheter.
In July 2023, Abbott received the FDA approval for the AVEIR dual chamber (DR) leadless pacemaker system, the world's first dual chamber leadless pacing system that treats people with abnormal or slow heart rhythms. With more than 80% of people needing a pacemaker requiring pacing in two chambers of the heart (both the right atrium and right ventricle), the approval significantly increases access to leadless pacing for millions across the United States.
In May 2023, Medtronic received FDA approval for its Micra AV2 and Micra VR2, the next generation of its industry-leading miniaturized, leadless pacemakers. Micra AV2 and Micra VR2, the world's smallest pacemakers, provide longer battery life and easier programming than prior Micra pacemakers, while still delivering the many benefits of leadless pacing such as reduced complications compared with traditional pacemakers.
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