A tiny pacemaker has been tailored by Medtronic and Children’s National Health System researchers for implantation in infants. The diminutive device, measuring only one cubic centimeter, can be implanted with a minimally invasive procedure that promises faster recovery times and shorter surgeries. Instead of using open-chest surgery, doctors could implant the tiny pacemakers by making a relatively tiny 1-cm incision just below the ribcage.

A patented two-channel, self-anchoring access port enables the operator to insert a camera into the chest to directly visualize the entire procedure. A sheath is then inserted through the second channel to access the pericardial sac surrounding the heart. The leadlet, the short extension of the miniature pacemaker, can be affixed onto the surface of the heart under direct visualization. The pacemaker is inserted into the incision and the skin is closed, leaving a tiny scar instead of two large suture lines.

The median time from incision to implantation in immature porcine models was 21 minutes, and the entire procedure took less than an hour on average. Conventional pediatric open-heart surgery could take up to several hours.

The miniature pacemakers and surgical approach may also be applicable to adult patients with limited vascular access, such as those born with congenital heart disease, or for patients who have had open-heart surgery or multiple previous cardiovascular procedures.

A paper describing the prototype and proof-of-concept testing was presented at the American Heart Association’s Scientific Sessions 2018 in Chicago.