Medtronic Begins RIO 2 Study of In-Office Procedures to Insert Medtronic's Reveal Linq ICM

May 7, 2015—Medtronic plc announced the first in-office implantation of the miniaturized Reveal Linq insertable cardiac monitor (ICM) as part of the Medtronic Reveal Linq In-Office 2 (RIO 2) study. The device was implanted in an office setting at Scripps Clinic in La Jolla, California, by cardiologist John Rogers, MD.

According to Medtronic, the RIO 2 study will determine if the Reveal Linq ICM procedure, when performed in an in-office setting, is as safe as procedures performed in a hospital setting, such as an operating room, cardiac catheterization laboratory, or electrophysiology laboratory.

RIO 2 is enrolling approximately 540 patients in 30 centers across the United States in a two-arm, prospective, nonblinded study in which patients will be randomized 1:1 to receive either the Reveal Linq ICM in an office setting or in a hospital setting. Patients will be followed for approximately 3 months and evaluated for procedure- and device-related complications, as well as for procedure time and resources required to perform the procedure.

Medtronic is also conducting the RIO 2 international study that will enroll approximately 150 patients in 15 centers across Europe, Australia, and Canada. This observational study will examine clinical evidence to support moving the Reveal Linq insertion procedure from the traditional hospital setting to new locations within the hospital (“out-of-cathlab”), stated Medtronic.

In the company’s press release, Dr. Rogers commented, “Studies such as RIO 2 may enable physicians to provide their patients with even greater access to the latest diagnostic tools and therapies. In-office procedures have the potential to help patients and reduce costs to the health care system.”

In February 2014, Medtronic announced US Food and Drug Administration 510(k) clearance, European CE Mark approval, and the global launch of the Reveal Linq ICM system, which is approximately 1 cc in size. The Reveal Linq allows physicians to continuously and wirelessly monitor a patient’s heart through the Carelink network for up to 3 years, with 20% more data memory than its larger predecessor, Reveal XT.