Boston Scientific (NYSE:BSX) said yesterday that it’s launching a study of its Emblem S-ICD device in older patients with diabetes who are at risk for sudden heart attack but unsuitable for implantable cardiac defibrillators, as it seeks parallel approvals for the new indication from the FDA and the Centers for Medicare & Medicaid Services.
The S-ICD, which Boston Scientific acquired from Cameron Health for $150 million in cash and another $1.05 billion in potential milestones back in 2012, delivers its regulating shock via subcutaneous leads. The newer Emblem model is 19% slimmer and projected to last 40% longer than the original S-ICD, Marlborough, Mass.-based Boston Scientific has said. If approved by the FDA and CMS, the new indication would be for patients age 65 and older with a history of heart attack, diabetes and moderately low left ventricular ejection fraction.
The 1,800-patient Madit S-ICD trial is designed to evaluate whether the Emblem S-ICD improves the survival rate in that group of patients, who do not meet the guidelines for conventional ICD implantation involving leads threaded through blood vessels into the heart, compared with patients’ current medical therapy. It’s 1 of 2 studies piloting Boston Scientific’s Win-Her program aiming to increase the enrollment of women in clinical trials, the company said. The 1st patient was enrolled by co-principal investigator Dr. Michael Guidici of the University of Iowa, Boston Scientific said.
“Our hypothesis is that the S-ICD device may reduce all-cause mortality in this high-risk cohort of cardiac patients with diabetes,” co-principal investigator Dr. Valentina Kutyifa, of the University of Rochester Medical Center, said in prepared remarks. “The value of eliminating unnecessary patient complications by implanting a defibrillator which does not require intracardiac leads was an important factor in our decision to utilize the S-ICD device when designing this trial.”
“In addition to the knowledge we hope to gain from this population of patients with diabetes, we are excited for the opportunity to improve the broad applicability of the Madit S-ICD trial results by increasing the enrollment of women in this study,” added SVP Dr. Kenneth Stein. “Moreover, the trial emphasizes our continued commitment to expanding access to all patients who may benefit from this proven technology.”
The Emblem S-ICD was approved in the U.S. and Europe in March 2015; CE Mark approval for magnetic resonance-conditional labeling in the European Union followed in April 2016, with FDA approval of the MR-conditional label coming in August of that year.