Medtronic Begins In-Office Trial for Reveal Linq Cardiac Monitor

Dublin, Ireland-based Medtronic Inc. has begun an in-office insertion trial for its miniaturized cardiac monitor, the Reveal Linq ICM (insertable cardiac moniter) system. The study, Reveal LINQ In-Office 2 (RIO 2), began in an office setting at Scripps Clinic in La Jolla, Calif., with an insertion performed by cardiologist John Rogers, M.D. The RIO 2 study will determine if the device insertion, performed in an in-office setting, is as safe as procedures performed in a traditional hospital setting, such as an operating room, cardiac catheterization laboratory or electrophysiology laboratory.

“Studies such as RIO 2 may enable physicians to provide their patients with even greater access to the latest diagnostic tools and therapies,” said Rogers. “In-office procedures have the potential to help patients and reduce costs to the healthcare system.”

RIO 2 is enrolling approximately 540 patients in 30 centers across the United States in a two-arm, prospective, un-blinded study in which patients will be randomized 1:1 to either receive the Reveal LINQ ICM in an office setting or in a traditional hospital setting. Patients will be followed for approximately three months and evaluated for procedure and device-related complications, and also for procedure time and resources required to perform the procedure.

The RIO 2 study also is enrolling approximately 150 patients in 15 centers across Europe, Australia and Canada. This observational study will examine clinical evidence to support moving the LINQ insertion procedure from the traditional hospital setting to new locations within the hospital, or “out-of-lab.”

“Physicians have embraced Reveal LINQ ICM for its ease of use, and moving the insertion procedure to the office setting has the potential to improve patient access to cardiac monitoring while enhancing the overall patient experience,” said Nina Goodheart, vice president and general manager of the Diagnostics business in Medtronic’s Cardiac Rhythm and Heart Failure division.

Cleared by the U.S. Food and Drug Administration (FDA) in 2014, the Reveal LINQ ICM System is the newest generation of ICM and the smallest cardiac monitor available (approximately 1 cc, or one-third the size of an AAA battery). The device is placed under the skin of the chest using a minimally invasive insertion procedure and allows physicians to continuously and wirelessly monitor a patient’s heart through the Carelink Network, Medtronic’s remote cardiac monitoring system, for up to three years. Common uses include monitoring syncope (fainting) patients for potential episodes of bradycardia (slow heartbeat), monitoring patients who have had cryptogenic strokes (strokes of unknown cause) for possible episodes of atrial fibrillation, and monitoring patients suffering from intermittent chest palpitations for potential episodes of atrial or ventricular arrhythmias.