Medtronic is embarking on a trial that could potentially move the Reveal LINQ, a subcutaneously implanted cardiac monitor (ICM) used to record EKGs in patients with arrhythmia-related symptoms, out of the traditional hospital setting and into the physician’s office. The Reveal LINQ was approved by the FDA in February 2014. It is the smallest ICM currently available in the market with dimensions of 44.8mm x 7.2mm x 4.0mm and a volume of 1.2cm³ as listed in Medtronic’s Reveal LINQ Product Specifications. Traditionally, these devices are implanted in the same settings as cardiac rhythm management devices, pacemakers, ICDs or CRTs, which are performed as sterile procedures in the OR, EP lab or Cardiac Catheterization Lab.
RIO2 Study to Determine Safety
Anytime a procedure is moved out of the sterile hospital environment, the primary concerns are infections and procedure complications. In order for the FDA to approve an alternative insertion practice, proof of safety has to be demonstrated, and Medtronic’s RIO 2 Study is set to do just that.
Medtronic is looking to enroll about 540 U.S. patients and 155 international patients in its RIO 2 study. These patients will be randomized 1:1 to have their Reveal LINQ devices inserted in either the traditional hospital setting, or the in-office setting. This study is set to run between March 2015 and December 2016. FDAnews Device Daily Bulletin reported on May 11, 2015 that the first in-office implant for this study was performed in La Jolla, California. This study will follow these patients for three months after insertion and compare events between the two insertion settings.
If the results show the in-office setting is as safe as the hospital setting, Medtronic will apply for an expanded FDA approval to include in-office insertions. As listed in the study’s Detailed Description, “moving the LINQ insertion procedure out of the traditional hospital setting may benefit the patient and reduce the burden to the healthcare system.” With the reduced size of the Reveal LINQ, remote monitoring capabilities and now potentially an in-office insertion setting, the convenience factor may help in both the physician’s and patient’s decision to have one of these devices implanted. This could result in the identification and ultimately the treatment of additional underlying arrhythmias.
Cost of the Reveal LINQ
As with any procedure, whether performed in the hospital or the physician’s office, cost is a concern. The Reveal LINQ has its advantages over other devices, but it comes at the steep cost of $5,295, which is $1,500 more than the average price of its predecessor, the Reveal XT, and $1,700 more than the average price of St. Jude’s Confirm. Even at the lowest offered price of $4,845 for high-volume purchases, this device is still nearly $1,500 more than its current competition.
Overall reimbursement rates for this procedure, including the explant, are currently at about $7,400. Once the costs of personnel and additional supplies are included, margins are very tight. With no similarly sized competitive device foreseen to enter the market in the near future, it remains to be seen whether Medtronic will offer a reduced price for this device to make the Reveal LINQ procedure more cost effective and an easier decision for physicians.
Please note all prices and reimbursement figures are from MD Buyline.