Engineering students at Purdue University have come up with what they say is a simple, cost-effective tool cardiac surgeons can use to test whether pacemaker leads have been securely anchored to heart tissue.
Leads are thin insulated wires that extend from a pacemaker and deliver electrical impulses to regulate the beating of the heart. A complication of standard pacemakers, along with infection, is lead failure. Although wireless pacemakers are undergoing testing trials by companies like St. Jude Medical ($STJ), Medtronic ($MDT), Boston Scientific ($BSX) and others, the FDA has yet to approve a wireless device for use in the U.S.
In the meantime, Purdue graduate biomedical engineering students Elizabeth Mercer and Johnny Zhang, along with former mechanical engineering students Jason Lee and Joseph Pellettiere, developed SafePace, which is a device they say could decrease the rate of lead dislodgment.
SafePace was designed with what they said is a current surgical practice of tugging on the leads to test their stability. Obviously, it is a highly subjective method because the amount of force used varies with each surgeon.
"Our mission in developing SafePace is to design a mechanical feedback system that increases a doctor's and patient's confidence in the stability of a pacemaker lead and reduces the probability of a lead being dislodged," Zhang said in a release.
The device is made up of two parts held together by a proprietary coupling that pulls apart with a specific force that indicates the lead is securely implanted, he said. It is undergoing additional testing required before it can begin the approval process.
Until then, the surgeon's tug test will have to suffice.
- read the release
- watch a SafePace video
Editor's Corner: The pacemaker inside me