Nanostim's leadless cardiac pacemaker proceeds in safety study
Nanostim, a small California startup, says it has successfully implanted a leadless cardiac pacemaker into 11 patients at a hospital in the Czech Republic.
That's a pretty impressive accomplishment in the company's ongoing LEADLESS study, a prospective, single-arm, multicenter trial designed to generate safety and effectiveness data for the device. Nanostim bills its device as the first totally self-contained pacemaker that doesn't require leads. It's designed to be implanted by way of a catheter through the femoral vein directly into the heart, avoiding the traditional leads or surgical pockets required for existing pacemakers.
Nanostim isn't the only one focused on developing a cardiac device that would eliminate or reduce wire connectors. Medtronic ($MDT) is developing a small, self-contained wireless pacemaker, for example. St. Jude Medical ($STJ) isn't developing one directly, but the company is a Nanostim investor, with a commitment to staged financing of the pacemaker depending on achieving certain development and clinical milestones. St. Jude also retains an exclusive option to acquire the company. Other investors include InterWest Partners, US Venture Partners, Emergent Medical Partners and Life Science Angels.