Medtronic aims to push insertion of world's tiniest cardiac monitor into the physician's office

Medtronic's Reveal Linq wireless cardiac monitoring implant--Courtesy of Medtronic

The world's smallest cardiac monitor implant is on track to make a move into the doctor's office. Medtronic's ($MDT) aim is to further capitalize upon a hugely successful launch of its Reveal Linq that's already exceeded all expectations with a potential for drug-like blockbuster annual sales of $1 billion to $2 billion.

The company has started a study of physician office insertion, in order to build further upon its standard hospital use. Upside for Medtronic lies not only in continuing to expand Linq sales, but also in grabbing market share for follow-on products that the monitor determines that these patients need.

Medtronic launched its Reveal Linq insertable cardiac monitor, which is only about one-tenth the size of its previous Reveal cardiac monitor product, in February 2014. The company said in March that the prior Reveal device had annual sales of about $100 million, but that Linq is already on the order of up to about a half-billion dollars in annualized sales with the potential to hit $1 billion to $2 billion in peak year sales.

"There's nothing like it really in the marketplace at this point. It's doing extremely well, great returns," summed up Medtronic CFO and EVP Gary Ellis at the Barclay's Capital Health Care conference in March.

The benefits of the Linq for Medtronic extend to the adoption of subsequent products from the company.

"Roughly 8% of those patients will wind up getting a pacemaker or ICD in the first year, and over the three to three and a half year life of a Reveal Linq, roughly 20% of those patients will be identified as being appropriate candidates for device therapy," said Medtronic Cardiac & Vascular Group President Mike Coyle on the February earnings call.

He continued, "So this is not only helping us with its own revenue, it's also helping us in terms of getting patients who need these therapies identified and appropriately treated. And obviously, we'd get differential market share of those patients because we're the ones who found them."

All this means that a lot is hanging in the balance for the study Medtronic has started to make Linq even more accessible to patients by enabling FDA clearance for physician office insertion.

Medtronic is going big with the study, dubbed RIO 2, with 540 patients at 30 U.S. centers and 150 patients at 15 centers in Europe, Australia and Canada.

The U.S. portion will randomize patients one-to-one to insertion of the Reveal Linq in either an in-office or traditional hospital setting. Patients will be followed for three months for procedure and device-related complications. Data on the procedure time and necessary resources will also be gathered. The ex-U.S. portion is an observational study examining the transition of its insertion from a traditional hospital setting, to less formal hospital settings that are out of the laboratory.

The Linq device is inserted through a small incision via an injection device about 8 mm under the skin of the chest over the heart. It has sufficient battery life to allow for three years of continuous monitoring. The device communicates wirelessly with a patient bedside monitor that uploads the device data to the Medtronic CareLink network for analysis and tracking.

The cardiac monitor is only about one cubic centimeter or one-third the size of a AAA battery. In addition to monitoring cryptogenic stroke patients, it can be used to monitor syncope patients for potential episodes of bradycardia/asystole and patients suffering from intermittent chest palpitations for potential episodes of atrial or ventricular arrhythmias.

"Studies such as RIO 2 may enable physicians to provide their patients with even greater access to the latest diagnostic tools and therapies," said Dr. John Rogers, a cardiologist who conducted the first in-office Linq insertion as part of the trial in his La Jolla, CA, office, said in a statement. "In-office procedures have the potential to help patients and reduce costs to the healthcare system."'

- here is the release

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