A new study of the so-called “leadless” defibrillator made by Boston Scientific (NYSE:BSX) shows that the device matches the safety and performance of standard defibrillators, which use leads threaded through blood vessels to deliver shocks to the heart.
The S-ICD device, which Boston Scientific acquired when it bought Cameron Health earlier this year, won pre-market approval from the FDA this week. Instead of transvenous leads, the S-ICD uses leads that are implanted subcutaneously. The shock therapy is delivered through the sternum to the heart.
The Effortless real-world study showed a rate of inappropriate shocks for the S-ICD of nearly 7%, about ½ that of the 330-patient investigational device exemption trial behind the FDA approval. Nearly 90% of ventricular fibrillation episodes were converted with the S-ICD, versus 90.8% for the control arm of the trial, according to heartwire. Complications rates were low and also comparable, according to the website.
One cause for concern was a 10.4% failed conversion rate, which was in line with the control arm but in stark contrast to the 0% rate from the pivotal trial of the S-ICD device. Standard ICDs typically fail to convert 2%-5% of the time.
Boston Scientific paid $150 million up front for Cameron Health in March, in a deal that could wind up being worth $1.35 billion.