News | Heart Valve Technology | November 07, 2017

Medtronic Unveils Strong Early Outcomes for Intrepid Transcatheter Mitral Valve Replacement System

First Report Investigation shows substantial mitral valve regurgitation reductions and versatility of dual-stent design

Medtronic Unveils Strong Early Outcomes for Intrepid Transcatheter Mitral Valve Replacement System

November 7, 2017 — Medtronic plc recently presented positive data for its self-expanding Intrepid transcatheter mitral valve replacement (TMVR) system in patients with severe, symptomatic mitral valve regurgitation. The data was presented as a First Report Investigation at the Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting, Oct. 29-Nov. 2 in Denver and simultaneously published in the Journal of the American College of Cardiology (JACC).

Data from the first 50 consecutive patients enrolled in the Intrepid Pilot Study demonstrated successful device implantation and a substantial reduction in mitral regurgitation at 30 days. The new data come on the heels of the first patient implant in the APOLLO trial, the first-ever pivotal trial approved by the U.S. Food and Drug Administration (FDA) to evaluate the safety and efficacy of the Intrepid TMVR system.

“These early outcomes with the Intrepid TMVR System are encouraging as we investigate a minimally-invasive alternative to surgical mitral valve replacement,” said Paul Sorajja, M.D., Headrick Family Chair, Valve Science Center at the Minneapolis Heart Institute Foundation and presenter of the Intrepid Pilot Study data at TCT. “The Intrepid TMVR System is easy to implant in the challenging mitral anatomy due to its conformable, dual-stent design and the device corrects the underlying mitral regurgitation in a significant majority of patients.”

The Intrepid Pilot Study was designed to evaluate valve safety and performance of the Intrepid TMVR System across sites in the United States, Europe and Australia. Initial 30-day outcomes showed that the Intrepid TMVR System was successfully implanted in 98 percent of patients. The early results also demonstrated notable reductions in mitral regurgitation, with patients experiencing either none/trace or mild mitral regurgitation at 30-days compared to moderate to severe at baseline. Patients also continued to have symptomatic improvements with 79 percent of patients classified as NYHA (New York Heart Association) class I or class II at their last follow-up.

“It is an exciting time for mitral valve replacement therapy as demonstrated by the promise of such truly innovative technologies that can positively impact patients suffering from mitral valve disease,” said Vinayak Bapat, M.D., cardiothoracic surgeon at Columbia University Medical Center/New York-Presbyterian Hospital, and principal investigator of the Intrepid Pilot Study. “We look forward to further investigation of the Intrepid TMVR System with the landmark APOLLO pivotal trial, which just got underway.”

The Intrepid TMVR system integrates self-expanding, dual-stent technology with a tissue valve to facilitate catheter-based implantation without the need for open-heart surgery. The Intrepid valve is compressed inside a hollow delivery catheter and is inserted between the ribs to enter the heart. The new replacement valve is expanded directly into the malfunctioning mitral valve. The outer stent frame is designed to attach and conform to the malfunctioning native valve without the need for additional sutures or tethers to secure the device in place. The inner stent houses the valve, which is made from bovine tissue and is intended to maintain blood flow.

The Intrepid TMVR system is available for investigational use only and it is not approved for use outside of clinical studies.

For more information: www.medtronic.com

 

Related Content

TCT 2017 Late-breaking Clinical Trial Presentations

Related Content

Feature | Cath Lab | September 14, 2021 | By Aaron Detate and Lars Thording
In the electrophysiology (EP) lab, hundreds
An example of the Medis QCA angiography imaging derived fractional flow reserve (FFR) assessment. This technology removes the need for pressure wires and adenosine used in traditional FFR assessments of the coronary arteries.

An example of the Medis QCA angiography imaging derived fractional flow reserve (FFR) assessment. This technology removes the need for pressure wires and adenosine used in traditional FFR assessments of the coronary arteries.

News | Cath Lab | July 22, 2021
July 22, 2021 — Medis Medical Imaging is partnering with CORRIB Core Lab and Sinomed in randomized clinical trial of
ast End Medical announced it received U.S. Food and Drug Administration (FDA) clearance for the company's SafeCross Transseptal Radiofrequency (RF) Puncture and Steerable Balloon Introducer System. The 3-in-1 system, which includes a steerable introducer sheath with an ultra-visible positioning balloon and radiofrequency (RF) puncture dilator, aims to provide a predictable and safe solution for electrophysiology (EP) and structural heart interventions requiring left atrial access.
News | Cath Lab | July 14, 2021
July 13, 2021 — East End Medical announced it received U.S.
There is a trend in interventional cardiology that is now being called “renalism,” where patients with poor renal function are being excluded from interventional procedures because they are automatically considered too high risk. However, some hospitals are also creating cardio-renal care teams so these patients can be cared for by a team of experts rather than interventional cardiologists going it alone. #SCAI21 #SCAI2021 Creating a card0-renal program.

There is a trend in interventional cardiology that is now being called “renalism,” where patients with poor renal function are being excluded from interventional procedures because they are automatically considered too high risk. However, some hospitals are also creating cardio-renal care teams so these patients can be cared for by a team of experts rather than interventional cardiologists going it alone.

Feature | Cath Lab | May 14, 2021 | By Dave Fornell, Editor
There is a trend in interventional cardiology that is now being called “renalism,” where patients with poor renal fun
Abbott recently announced its new interventional imaging platform powered by Ultreon 1.0 Software, has gained European CE marked. This first-of-its-kind imaging software merges optical coherence tomography (OCT) intravascular imaging with the power of artificial intelligence (AI) for enhanced visualization. The new Ultreon Software can automatically detect the severity of calcium-based blockages and measure vessel diameter to enhance the precision of physicians’ decision-making during coronary stenting proc

Abbott recently announced its new interventional imaging platform powered by Ultreon 1.0 Software, has gained European CE marked. This first-of-its-kind imaging software merges optical coherence tomography (OCT) intravascular imaging with the power of artificial intelligence (AI) for enhanced visualization. The new Ultreon Software can automatically detect the severity of calcium-based blockages and measure vessel diameter to enhance the precision of physicians’ decision-making during coronary stenting procedures.

News | Cath Lab | May 12, 2021
May 12, 2021 — Abbott recently announced its new interventional imaging platform powered by Ultreon 1.0 Software, has
SCAI 2021 late-breaking presentations included the data on the Medtronic Harmony transcatheter pulmonary valve, cutting radial access hemostasis time by 50 percent, improving cardiogenic shock survival to 71 percent, and data showing very high mortality in COVID patients who suffer a STEMI heart attack. #SCAI21 #SCAI2021

SCAI 2021 late-breaking presentations included the data on the Medtronic Harmony transcatheter pulmonary valve, cutting radial access hemostasis time by 50 percent, improving cardiogenic shock survival to 71 percent, and data showing very high mortality in COVID patients who suffer a STEMI.

Feature | Cath Lab | May 06, 2021 | By Dave Fornell, Editor
April 29, 2021 — Here is the list of late-breaking study presentations and links to articles about each of them from
Most Stable Ischemic Heart Disease Patients Did Not Meet ISCHEMIA Trial Enrollment Criteria, raising questions about its application in real-world practice. #SCAI2021 Getty Images

Getty Images

News | Cath Lab | May 03, 2021
May 3, 2021 – Results from a new study find a broad range of patients who typically undergo revascularization for sta
New study demonstrates depression, HIV, mental health, obesity, alcohol and drug abuse are risk factors on most common type of heart disease in young black patients. Photo by Dave Fornell
News | Cath Lab | April 29, 2021
April 29, 2021 – A retrospective analysis of risk factors for coronary artery disease (CAD) in young African American
There are far fewer patients coming to hospitals with heart attacks during the COVID-19 pandemic as compared to averages prior to the pandemic. This has raised concerns that delayed treatment will cause an uptick in cardiac deaths and heart failure. Photo from Getty Images 

There are far fewer patients coming to hospitals with heart attacks during the COVID-19 pandemic as compared to averages prior to the pandemic. This has raised concerns that delayed treatment will cause an uptick in cardiac deaths and heart failure. Photo from Getty Images 

News | Cath Lab | April 28, 2021
April 28, 2021 – Results from a retrospective observational study, presented today at...