Technology | Stent Grafts | February 07, 2019

Medtronic Receives FDA Approval for Valiant Navion Thoracic Stent Graft System

Next-generation thoracic endovascular repair device expands applicability to broader range of patients

Medtronic Receives FDA Approval for Valiant Navion Thoracic Stent Graft System

February 7, 2019 — Medtronic plc recently received U.S. Food and Drug Administration (FDA) approval for the Valiant Navion thoracic stent graft system. The device is indicated for the minimally invasive repair of all lesions of the descending thoracic aorta, including thoracic aortic aneurysms (TAA), blunt thoracic aortic injuries (BTAI), penetrating atherosclerotic ulcers (PAU), intramural hematomas (IMH) and aortic type B dissections (TBAD).

Until now, patients with small iliac arteries were considered ineligible for thoracic endovascular aneurysm repair (TEVAR), or required adjunctive procedures to accommodate calcification and tortuosity concerns. Valiant Navion allows for the potential for more patients to receive a percutaneous procedure and overcome these anatomical concerns, enabling a less invasive approach to treatment compared to surgical cut-down (open) procedures.

The Valiant Navion is a lower-profile evolution of the Valiant Captivia thoracic stent graft system, which has treated more than 100,000 patients globally. Valiant Navion is built on the design philosophy of the Valiant Captivia system for improved performance and increased patient applicability. The system also features both CoveredSeal (proximal covered) and FreeFlo (proximal bare metal) stent configurations, providing physicians with two graft options to treat varying patient anatomies and pathologies.

“A significant reduction of the delivery system profile enables physicians to better facilitate the endovascular treatment of patients with smaller, tortuous, and calcified access vessel arteries,” said Ali Azizzadeh, M.D., the U.S. principal investigator for the Valiant Navion IDE study. “Furthermore, the challenging anatomical and comorbid baseline characteristics and resulting clinical evidence of the global investigational device exemption (IDE) subjects support this design.”

Approval was based on 30-day primary endpoint analysis of 87 subjects consecutively enrolled in the international, multicenter, prospective investigational device exemption (IDE) study analyzing the safety and efficacy of Valiant Navion in subjects with TAA and PAU. The study included a challenging real-world patient population with 37.9 percent female enrollment and 71.3 percent subjects with severe to life-threatening systemic disease (ASA physical status classification III/IV). The results demonstrated efficacy, with:

  • FreeFlo configuration implanted in 74.7 percent of procedures with no instances of access or deployment failures at implant in the full study cohort; and
  • The new CoveredSeal proximal configuration implanted in 25.3 percent of procedures with no instances of access or deployment failures at implant in the full study cohort.

The majority of procedures (50.6 percent) were performed through a percutaneous access approach, leading to operational efficiency with mean procedure and fluoroscopy times of 88.7 ± 53.4 minutes and 12.2 ± 8.8 minutes, respectively.

Through 30 days, data showed low rates of peri-operative mortality at 2.3 percent (2/87) and secondary procedures at 2.3 percent (2/87). The rate of Type Ia endoleaks was 1.2 percent (1/87) at one-month imaging follow-up.

For more information: www.medtronic.com

Related Content

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...
A cardiac cath lab at Henry Ford Hospital in Detroit. Photo by Dave Fornell

A cardiac cath lab complex PCI case at Henry Ford Hospital in Detroit. Photo by Dave Fornell

News | Cath Lab | April 28, 2021