Tele: 561.316.3330
Breaking Medical Device News

Friday, October 15, 2021
HomeMEDTRONIC plcAbre Venous Self-Expanding Stent System Receives FDA Approval Reports Medtronic

Abre Venous Self-Expanding Stent System Receives FDA Approval Reports Medtronic

October 27, 2020

Abre venous self-expanding stent system has received FDA approval. The news was announced today by Medtronic.

Abre venous self-expanding stent system device is indicated for use in the iliofemoral veins in patients with symptomatic iliofemoral venous outflow obstruction, also known as deep venous obstruction.

Deep venous obstruction occurs when the veins in the deep venous system become obstructed, blocked and/or compressed causing restricted blood flow to the heart. If left untreated, patients can experience leg discomfort and pain, limiting their mobility and quality of life. Symptoms of the disease include leg swelling, skin changes, leg ulcers, and pain. Severe complications can occur, such as blood clots that migrate to the lungs (pulmonary embolism), a clot in the leg called a deep vein thrombosis (DVT), or the formation of fibrotic tissue or scarring caused by a chronic DVT (post thrombotic syndrome).

The FDA approval is based on 12-month results from the ABRE clinical study, presented at the 2020 Charing Cross Symposium. The ABRE study assessed the safety and effectiveness of the investigational Abre stent in 200 patients with iliofemoral venous outflow obstruction across the spectrum of deep venous obstruction including those with post thrombotic syndrome, non-thrombotic iliac vein lesions (NIVL), and those who presented with an acute deep vein thrombosis (aDVT).

The study also included a challenging patient population, 44% (88/200) of whom required stents that extended below the inguinal ligament into the common femoral vein (CFV). The study met its primary safety endpoint with a 2.0% (4/200) rate of major adverse events (MAEs) within 30 days.1 The study also met its 12-month primary effectiveness endpoint with an overall primary patency rate of 88.0% (162/184).2 Despite the challenging patient population, no stent fractures and no stent migrations were reported in the study.

“Patients with deep venous obstruction are often younger, therefore it’s critical to have a venous stent that is not only safe and effective, but also strong and flexible,” said Erin Murphy, M.D., F.A.C.S., global principal investigator for the ABRE clinical study and director of Atrium Health Sanger Heart & Vascular Institute’s Venous and Lymphatic Program in Charlotte, North Carolina. “With FDA approval, we now have this important tool in our arsenal to treat patients with even the most challenging of deep venous lesions.”

Abre venous self-expanding stent system, self expanding system, is intended for permanent implant and utilizes an open-cell design with three off-set connection points to enable flexibility and stability during deployment. Abre also offers a balance of strength, flexibility, and fatigue resistance. Based on data presented at the Leipzig Interventional Course (LINC) 2020 annual meeting by Stephen Black, M.D., consultant and vascular surgeon, Guy’s, and St. Thomas’ Hospital and Kings College in London, the Abre stent system demonstrated a 0% fracture rate in bench testing simulated out to 50 years.3

“With Abre, our goal was to create a dedicated venous stent that combined a balance of the key characteristics necessary to treat patients with a broad spectrum of deep venous obstruction,” said Carolyn Sleeth, vice president and general manager of the endoVenous business, which is part of the Cardiac and Vascular Group at Medtronic. “We are excited to bring Abre to the U.S. market, which we believe will provide both physicians and patients with a new option backed by clinical evidence to treat this disease safely and effectively.”

Abre venous self-expanding stent system received CE (Conformité Européene) Mark approval in April of 2017 and is also intended for use in the iliofemoral veins for treatment of symptomatic venous outflow obstruction.

In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

Global Healthcare Exchange Announces Acquisition of Explorer Surgical

Explorer Surgical will operate as a wholly-owned subsidiary of GHX.

Arlington Scientific Broadens Product Portfolio and Further Expands its Product Offering Through the acquisition of Non-Mammalian Blocking Buffers

Arlington Scientific, Inc. (ASI) is pleased to announce that it has acquired the non-mammalian blocking buffer product line from Clark McDermith, former owner of...

Laborie Medical Technologies Acquires Pelvalon

Laborie was represented by Piper Sandler (financial advisor) and Simpson Thacher & Bartlett LLP (legal advisor). Pelvalon was represented by J.P. Morgan Securities LLC (financial advisor) and Dorsey & Whitney LLP (legal advisor).

Herculite Products, Inc. Promotes Two Employees to New Roles

Paul Flaherty Chief Strategy Officer and Marco Angelone is being promoted to the role of Chief Financial Officer.

Prof. Joseph Kvedar Added to the Sweetch Advisory Board Member

Prof. Josdeph Kvedar is the current chair of the board at the American Telemedicine Association (ATA), formerly VP of Connected Health at Mass-Gen Brigham, co-chair of the American Medical Association (AMA) Digital Medicine Payment Advisory Group, and author of The Internet of Healthy Things and The New Mobile Age.

Sid Bala Named President of HealthChampion

Sid Bala is the former president and chief executive officer of alligatortek, a custom software applications company that was acquired by HealthChampion in 2020 where he led them for 27 years after he founded the business

Cochlear Announces FDA Approval and Clearance of first-of-its-kind Remote Care Capabilities for Nucleus and Baha Systems

The FDA approval for the cochlear implant solution and FDA clearance for the Baha solution is the first step in commercializing the product offering, anticipated spring 2022, and complement Cochlear's existing Remote Care offerings.

By using this website you agree to accept Medical Device News Magazine Privacy Policy