Summary: Cardiac pacing has become a common medical procedure; however, current approaches inevitably involve inserting wires (leads) into the veins with attachment to the inside of the heart, resulting in significant complications. AtaCor Medical, Inc. (AtaCor) is developing a novel pacing system that delivers bradycardia pacing therapy without the need for vascular access or device placement within or on the heart. The implant procedure is accomplished by a custom delivery tool that avoids the need for fluoroscopy and can be performed within 5 minutes. Benefits of AtaCor’s system include (1) avoidance of endovascular device complications, (2) preservation of the vasculature for future endovascular therapies, (3) a solution for patients without vascular access due to congenital disease or prior device complications, and (4) a shorter procedure without fluoroscopically-guided lead placement, which reduces the costs, logistics and risks for patients, clinicians and healthcare institutions. The AtaCor system is intended to provide an innovative approach to deliver life-saving bradycardia pacing therapy without the complications associated with current methods.
Need: Current cardiac pacemakers inevitably involve invasion of the vasculature and heart, with significant short- and long-term complications. Complication rates associated with temporary and permanent pacing is ~20% and ~15%, respectively. Furthermore, the time delay associated with current emergency temporary pacing insertion significantly delays life-saving therapy delivery. AtaCor is developing a novel pacing system that will deliver temporary and permanent bradycardia pacing therapy without the need for vascular access or device placement within or on the heart. Additionally, the insertion procedure can be performed in ~5 minutes without any need for medical imaging.
Value: AtaCor’s technology can delivery live-saving cardiac pacing without placing any leads or hardware into the veins or heart. The technology allows physicians to rapidly deploy pacing therapy in the patient’s existing bed location, without moving the patient to the cath lab or requiring a radiology team with portable medical imaging, thereby greatly reducing the time to deliver, and the hospital’s cost for, temporary/emergency pacing lead insertion. Furthermore, AtaCor’s permanent pacing system creates a novel new treatment option for patients, especially those at greater risk for transvenous lead placement.