Trial launched to study in-office implantation of insertable cardiac monitor

Medtronic announced the launch of a study of an insertable cardiac monitor in an in-office setting.

The RIO 2 study with compare patients who receive the insertable cardiac monitor (Reveal LINQ) in an office setting vs. those who receive it in a hospital setting, according to a press release from the company.

The two-arm, prospective, unblinded study will enroll approximately 540 patients in 30 United States centers, according to the release. Patients will be evaluated for procedure- and device-related complications, as well as for procedure time and resources required to perform the procedure. Follow-up will be for approximately 3 months. In addition, the company is sponsoring an observational study of approximately 150 patients in 15 centers across Europe, Australia and Canada to examine clinical evidence to support moving the insertion procedure from the traditional hospital setting to new locations within the hospital.

“Studies such as RIO 2 may enable physicians to provide their patients with even greater access to the latest diagnostic tools and therapies,” John Rogers, MD, FACC, director of cardiac pacing and tachyarrhythmia device therapy at Scripps Clinic, La Jolla, Calif., who performed the first in-office insertion of the monitor, said in the release. “In-office procedures have the potential to help patients and reduce costs to the health care system.”

According to the release, the 1-cc device was cleared by the FDA last year; is inserted through a minimally invasive procedure into the patient’s skin; and transmits signs of cardiac disorders including atrial fibrillation, ventricular arrhythmias, bradycardia and stroke to physicians through the wireless Carelink Network.