FDAnews Device Daily Bulletin
Medical Devices / Research and Development

Medtronic Enrolls First Patients in Study Evaluating ICDs in Developing Countries

March 31, 2014

Medtech giant Medtronic has enrolled the first patients the Improve SCA study to evaluate the benefits of implantable defibrillators in high-risk primary prevention patients in developing countries. The patients were enrolled at Sichuan University’s West China Hospital and Fuwai Hospital in Beijing.

The prospective, nonrandomized study will potentially use any Medtronic single-, dual- or triple-chamber defibrillator that has received appropriate regulatory approval, Medtronic spokesman Joey Lomicky told Device Daily Bulletin. Improve SCA is the first study to look at the benefits of implantable cardioverter defibrillators and implantable resynchronization therapy defibrillators in countries where they are not commonly used for primary prevention.

ICDs administer electrical shocks or pacing therapy to stop a chaotic heart rhythm, whereas CRT-Ds use small electrical pulses to resynchronize the contractions of the heart’s ventricles.

The Minneapolis, Minn., devicemaker expects to eventually enroll 4,800 patients in more than 15 countries in Central and Eastern Europe, India, Asia, the Middle East, Africa and Latin America in Improve SCA. The patients must have no prior episodes of life-threatening arrhythmia and will be assessed based on the American Heart Association’s Class I guidelines for treatment recommendations for heart failure patients.

The trial results should be available by 2019, Lomicky said. — Lena Freund

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