Irish medical technology firm Medtronic has commenced the Reveal LINQ In-Office 2 (RIO 2) Study through successfully implanting world's smallest cardiac monitor in an office setting at Scripps Clinic in La Jolla, California.
The RIO 2 study will compare the safety and effectiveness of the Reveal LINQ Insertable Cardiac Monitor (ICM) in an in-office setting and a traditional hospital setting such as an operating room, cardiac catheterization laboratory or electrophysiology laboratory.
According to the company, the study will determine whether the Reveal LINQ ICM procedure carried out in an in-office setting is as safe as procedures performed in a traditional hospital setting.
The company will enroll around 540 patients in 30 centers across the US 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 assessed for around three months to find out procedure and device-related complications, as well as for procedure time and resources required to perform the procedure.
In addition, the study will enroll around 150 patients in 15 centers across Europe, Australia and Canada, which will study clinical evidence to support moving the LINQ insertion procedure from the traditional hospital setting to new locations within the hospital, or out-of-lab.
Medtronic cardiac rhythm and heart failure division diagnostics business vice-president and general manager Nina Goodheart said: "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."
The Reveal LINQ ICM received approval from the US Food and Drug Administration in 2014. It is placed under the skin of the chest using a minimally invasive insertion procedure, which helps physicians to continuously and wirelessly monitor a patient’s heart through the Carelink Network for up to three years.
Image: Medtronic operational headquarters, Minneapolis. Photo: courtesy of Medtronic, Inc.