Medtronic wins FDA nod for Azure remote monitoring equipped pacers

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Medtronic logoMedtronic (NYSE:MDT) said today it won FDA approval for its portfolio of Azure pacemakers with BlueSync patient monitoring technology.

The clearances cover both the Azure XT MRI and Azure S MRI pacers including single chamber and dual chamber models, the Fridley, Minn.-based company said. The newly cleared pacers have estimated lifespans of 13.7 years for dual chamber pacers, which Medtronic estimates is 27% longer than the earlier-gen devices.

The Azure portfolio of pacers feature the company’s BlueSynch technology which allows for automatic remote monitoring through the company’s CareLink network, and its Azure XT device features the Reactive ATP algorithm intended to slow the progression of atrial fibrillation.

“With the approval of Azure, clinicians managing patients with bradycardia now have pacemakers with improved longevity, and better ability to detect and reduce atrial fibrillation. BlueSync technology with Azure also enables secure and automatic wireless data transmission to clinicians. Remote monitoring with automatic data transmissions can result in earlier clinical decisions and improved patient monitoring compliance,” cardiac rhythm & heart failure division prez Dr. John Liddicoat said in a press release.

Medtronic said that in connection with the approval, its Percepta line of cardiac resynchronization therapy pacers now include BlueSync tech for remote monitoring through the CareLink network.

Earlier this month, Medtronic released its preliminary second quarter earnings, estimating the impact of Hurricane Maria at approximately $55 to $65 million, or 3¢ on its second quarter non-GAAP earnings per share.

Medtronic launches pivotal trial of Intrepid TMVR system

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Medtronic (NYSE:MDT) said today it launched a pivotal trial of its Intrepid transcatheter mitral valve replacement system after winning FDA investigational device exemption for the device.

The 1st patient in the trial was enrolled at Milwaukee’s Aurora St. Luke’s Medical Center, the Fridley, Minn.-based company said.

The Apollo trial is slated to enroll up to 1,200 patients with severe, symptomatic mitral valve regurgitation into 2 cohorts with a primary endpoint of composite of all-cause mortality, all-stroke, reoperation or reintervention and cardiovascular hospitalization at 1 year.

Secondary endpoints in the trial include quality of life measures and valve performance in patients with severe symptomatic mitral regurgitation.

“This is the beginning of an important journey to establish a truly less invasive approach to treat severe mitral valve regurgitation in patients who are appropriate candidates for mitral valve replacement with a transcatheter technology that eliminates the need for open-heart surgery,” trial co-principal investigator Dr. David Adams of Mount Sinai Health System said in a prepared statement.

The trial will examine patients in 2 cohorts, split between 650 patients who are candidates for conventional open-heart mitral valve replacement surgery and not eligible for mitral repair and 550 patients who are too high risk for open-heart mitral valve surgery.

Patients in the 1st cohort will be randomized to either receive the Intrepid TMVR system or a conventional mitral valve surgery, with a primary endpoint to demonstrate the Intrepid’s non-inferiority to conventional surgery at 1 year. The 2nd cohort’s primary endpoint is designed to demonstrate statistical non-inferiority to a performance goal at 1 year, Medtronic said.

“We worked closely with the FDA and leading physicians to design a trial that will compare the Intrepid TMVR system with the current standard of care for patients with mitral regurgitation. We are excited to investigate whether this technology holds promise for the large number patients suffering from the debilitating symptoms of severe mitral regurgitation,” Medtronic coronary & structural heart division prez Sean Salmon said in a prepared release.

The Intrepid system features self-expanding, dual-stent technology and a replacement tissue heart valve to allow for catheter-based implantation. The valve is compressed inside a hollow delivery catheter inserted between the ribs to enter the heart and is expanded directly into the malfunctioning mitral valve, the company said. The outer stent is designed to attach and conform to the native valve without sutures or anchors while the inner stent houses the valve, made from bovine tissue.

“The Intrepid system features a truly innovative dual-stent design and the trial will investigate its safety and efficacy in addressing severe symptomatic mitral regurgitation replacing the need for an open-heart procedure. We look forward to working with the APOLLO Trial clinical sites in the U.S. and around the world,” trial co-principal investigator Dr. Martin Leon of Columbia University Medical Center/New York-Presbyterian Hospital said in a prepared statement.

Earlier this month, Medtronic said it won expanded FDA approval for its Endurant II and IIs stent graft systems designed to treat abdominal aortic aneurysms, now indicated for use in combination with the Heli-FX EndoAnchor system to treat patients with short, hostile aortic neck anatomies.

Heart Societies update guidelines to support cardiac monitors for syncope patients

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Medtronic (NYSE:MDT) said today that new guidelines from the American College of Cardiology, the American Heart Association and the Heart Rhythm Society now recommend the use of cardiac monitors for patients with syncope.

The updated guidelines for patients with syncope, or unexplained fainting, was published online in the Journal of the American College of Cardiology, Circulation and HeartRhythm.

Medtronic said that the new guidelines support the use of its Seeq MCT system, a wireless continuous external heart monitor that can be worn up to 30 days, and its Reveal Linq ICM with TruRhythm detection, an implantable monitor placed just beneath the skin which allows for wireless monitoring for up to 3 years.

“The causes of syncope can be difficult to diagnose as episodes are usually infrequent and unpredictable. Detection with short-term monitoring techniques is often unsuccessful and, as a result, patients may see several different specialists and undergo multiple tests without receiving a conclusive diagnosis. When the cause of syncope is unclear, continuous long-term cardiac monitoring has become the standard of care, particularly in early stages of evaluation,” Dr. David Benditt of the University of Minnesota’s Cardiac Arrhythmia Center said in a prepared statement.

The new guidelines recommend both external and implantable cardiac monitors based on the frequency of symptoms, with implantable cardiac monitors receiving a stronger recommendation based on evidence from randomized controlled trials of such devices, Medtronic said.

“Medtronic is committed to bringing meaningful innovations that help patients lead healthier lives, while providing clinicians with the best tools so that they can efficiently and effectively diagnose and treat their patients,” Medtronic patient monitoring & diagnostics VP & GM Nina Goodheart said in a press release.

The company won FDA approval for a next-gen Reveal Linq insertable cardiac monitor with TruRhythm Detection last week.

The Linq ICM with TruRhythm Detection offers exclusive algorithms which the company said resulted in a 95% reduction in false bradycardia episodes and a 47% reduction in false pause episodes compared with the previous-gen version of the device.

Last September, Medtronic launched the Linq device in Japan after winning approval from the Ministry of Health, Labor & Welfare.