October 15th, 2013
First Leadless Pacemaker Gains Approval in Europe
Larry Husten, PHD
St. Jude Medical announced on Monday that the world’s first leadless pacemaker has gained CE Mark approval in Europe. The company also announced that it was buying Nanostim, the company that developed the innovative device. The FDA recently granted conditional approval for an Investigational Device Exemption (IDE) application and a pivotal clinical trial, St. Jude also reported.
The new leadless pacemaker is implanted directly inside the heart through a catheter. The single-chamber VVIR device has an expected battery life of about 8-10 years.
Initial results from the first-in-man LEADLESS study were presented in May at the Heart Rhythm Society meeting. The device was successfully implanted in 32 out of 33 patients. The mean procedure time was 28 minutes, and the performance of the device was said to be comparable to that of a conventional pacemaker. The great advantage of the device is that it may not cause the complications associated with pacemaker leads. However, as reported by Wells Fargo analyst Larry Biegelsen, one patient in the trial had a cardiac perforation and tamponade, which resulted in the patient’s death.
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