Medical device company Abbott Laboratories announced this month the world’s first patient implants of Aveir, the company’s investigational dual-chamber leadless pacemaker.
Every member of the Abbott team who works at the company’s Sylmar site played an integral role in bringing Aveir to clinical trial alongside other Abbott employees across the country, according to Heidi Hinrichs, divisional vice president of global clinical and regulatory affairs for cardiac rhythm management.
Leadless pacemakers such as Aveir are implanted directly into the heart through a minimally invasive catheter-based procedure, eliminating the need for cardiac leads used by traditional pacemakers. Leadless pacemakers work like traditional pacemakers to regulate heart rate and offer reduced lead-related complications and a less restrictive recovery period due to the minimal invasiveness of the procedure.
The clinical safety and efficacy of Aveir is being evaluated through the Aveir DR i2i study. The first implant was performed at Na Homolce Hospital in Prague, Czech Republic.
“As leadless pacing technology has evolved, we’ve always viewed dual chamber leadless technology as a therapy evolution that would have a dramatic impact on more patients – but a technology that was going to be very challenging to develop,” Dr. Reinoud Knops, clinical trial steering committee co-chair, said in a statement. “That we have reached this point in time where dual chamber pacing without leads has become a reality is a monumental moment for modern medicine.”
According to Hinrichs, it is estimated that 1.25 million pacemakers are implanted every year worldwide, of which more than 200,000 are implanted in the United States. About 80 percent of the patients need a dual-chamber pacemaker because their condition requires pacing in two chambers of the heart.
Hinrichs did not comment on the cost of making an Aveir unit or what kind of financial impact a commercialized form of the device could have for the company, citing corporate policy.
If approved, Aveir could be the first pacemaker to offer dual-chamber leadless pacing.
“The Aveir DR dual-chamber leadless pacemaker builds upon our Aveir VR single-chamber leadless platform, and we believe that once approved these systems have the potential to change the way doctors approach the treatment of abnormal heart rhythms,” Randel Woodgrift, senior vice president of Abbott’s cardiac rhythm management business, said in a statement.