Boston Scientific Corporation (BSX) announced receipt of the CE Mark approval of its X4 line of quadripolar CRT-D systems, including the AUTOGEN X4, DYNAGEN X4, and INOGEN X4 cardiac resynchronization therapy defibrillators (CRT-Ds), a suite of ACUITY X4 quadripolar LV leads and the ACUITY PRO lead delivery system. Leads are the wires that connect defibrillators and pacemakers to the heart.
The ACUITY X4 suite of quadripolar LV leads is uniquely designed with multiple electrode spacing configurations to accommodate individual patient anatomy. The 3D spiral further maximizes electrode contact with the myocardium and minimizes pacing capture thresholds in non-apical locations. More importantly, the multiple fixation option of the device assist the medical professionals reach the difficult vessels, which were inaccessible till now, by other available quadripolar leads.
Extensive observation and research done by the World Health Organization (WHO), has led to the finding that 80% of the premature heart disease and stroke is preventable. Therefore, it is believed that that the new offering will act as a boon for the patients and help save lives.
The vital approval opens the scope for commercialization of the medical device across Europe. It is believed that the Cardiac Rhythm Management (CRM) business of the company will considerably gain from the new approval as the segment is slowly returning to growth.
The first implant of the AUTOGEN X4 CRT-Ds was successfully accomplished in Civili Hospital, Brescia, Italy. According to the WHO, Cardiovascular disease (CVD) account for more than half of all deaths across the European Region.
The CE Mark ensures wide recognition of the product throughout the European region. The important approval is also expected to enhance greater adoption as both medical professionals and patients can rely on the effectiveness of the product.
Boston Scientific further announced that following the CE mark, it plans to start a global clinical study of the same covering 1000 patients.
Currently, the stock carries a Zacks Rank #2 (Buy). Investors interested in the medical products industry can look into stocks like Hill-Rom Holdings, Inc. (HRC), NuVasive, Inc. (NUVA) and Mead Johnson Nutrition Co. (MJN). While Hill-Rom sports a Zacks Rank #1 (Strong Buy), NuVasive and Mead Johnson holds a Zacks Rank #2 (Buy).
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