Boston Scientific Corporation BSX has commenced a global, multi-center UNTOUCHED trial to evaluate the clinical efficiency of its Emblem Subcutaneous Implantable Defibrillator (S-ICD) System.
This move reflects the medical technology giant’s consistent efforts to strengthen its position in the global multi-billion dollar cardiac rhythm management (CRM) devices market.
The primary aim of the study is to estimate the rate and causes of shocks in patients suffering from severely reduced cardiac function, who have been implanted with the Emblem S-ICD System. The results will allow physicians to take appropriate measures for primary prevention of sudden cardiac arrest (SCA) in such patients.
Management plans to enroll a minimum of 2,015 patients in this study at up to 200 centers globally. Enrollments in the U.S. will begin later this summer.
For years, implantation of transvenous ICD (TV-ICD) devices in cardiac patients has been a conventional treatment option practiced by most physicians worldwide. These devices, however, create several complications on grounds of the difficulty faced in maintaining long-term lead integrity and vascular access.
With an aim to address this issue, Boston Scientific developed the Emblem next-generation S-ICD system. According to the company, the S-ICD system can be placed just under the skin. It provides a patient the same protection from cardiac arrests as TV-ICDs. However, it leaves the heart and vasculature untouched thus minimizing the risk of complications associated with TV-ICDs.
We note that primary prevention cardiac patients, who are at high risk of SCA, represent the majority of heart patients in need of TV-ICDs in the U.S. and European Union. Through the UNTOUCHED study, management aims at establishing the superior clinical efficacy of the S-ICD system in such patients over TV-ICDs.
For this purpose, management plans to compare the results of the UNTOUCHED study with that of the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) study – over an 18-month follow-up period. The purpose will be to compare the performance of Emblem S-ICD with TV-ICDs (used in the MADIT-RIT study) in reducing the incidence of inappropriate shocks in primary prevention patients.
We believe, if the trial results come out in favor of Boston Scientific, demand for the S-ICD device will rise, eventually generating higher revenues at the company’s CRM business division.
Boston Scientific’s Emblem S-ICD System has recently been made commercially available in the U.S. The full U.S. launch should be over by the third quarter of 2015. With the global CRM devices market expected to reach a value of $20.9 billion by 2017, we believe Boston Scientific is poised to be a major player in the space, backed by the aforementioned developments.
Currently Boston Scientific carries a Zacks Rank #3 (Hold). Some better-ranked medical product stocks are Bio-Rad Laboratories, Inc. BIO, Hospira Inc. HSP and INSYS Therapeutics, Inc. INSY. All the three stocks sport a Zacks Rank #1 (Strong Buy).
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