Medtronic (NYSE:MDT) said it’s launching a clinical trial to compare in-office implantation of its Reveal Linq cardiac monitor with hospital implantation.
The Reveal Linq device is designed to be implanted beneath the skin on the upper left side of the chest and is indicated for monitoring patients experiencing dizziness, palpitation, fainting or syncope, chest pain and cardiac arrhythmias. Billed as the world’s smallest cardiac monitor, it’s about ⅓ the size of a triple-A battery, Medtronic said, and is designed to work for 3 years using the company’s CareLink network.
The 3-month Rio 2 trial is slated to enroll 540 patients in the U.S., the company said. It’s a 2-arm, prospective, unblinded study designed to randomize patients 1:1 for either in-office or in-hospital implantation of the Reveal Linq monitor, according to a press release. Another 150 patients are expected for an "out-of-lab" observational arm of the Rio 2 study in Europe, Australia and Canada designed to evaluate moving Reveal Linq implantations out of the cath lab to other hospital areas, Medtronic said.
"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 healthcare system," Dr. John Rogers of the Scripps Clinic in La Jolla, Calif., who performed the trails 1st in-office procedure, said in prepared remarks.
The FDA cleared Reveal Linq last year. In February, the company said a real-world study of the device in cryptogenic stroke patients showed that it detected atrial fibrillation at an even greater rate than found in a prior study.
"Physicians have embraced Reveal Linq [implantable cardiac monitor] 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," vice president Nina Goodheart said.
