FIRST IN-HUMAN IMPLANT OF NEWLY APPROVED LARGE-DIAMETER TAPERED GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM

Treatment options expand for patients with thoracic aortic disease states.

Tokyo, Japan. (March 17, 2025) – W. L. Gore & Associates (Gore) today announced the PMDA approval, and first in-human implant of large-diameter tapered devices from the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System product line.

News of the case, completed at The Jikei University School of Medicine by Takao Ohki, MD, PhD, Professor and Chief of the Division of Vascular Surgery, comes in conjunction with PMDA approval of four new tapered sizes ― 34x28 mm, 37x31 mm, 40x34 mm and 45x37 mm ― complimenting Gore’s existing selection of tapered and straight thoracic devices.

Indicated for the endovascular repair of the descending thoracic aorta, including aneurysms, transections and complicated Type B Dissections, the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System is a trusted treatment choice, first approved for use in Japan in 2019, with a staged delivery system designed for controlled precision.

Dr. Ohki commented, “these new large-diameter tapered devices are a great option for patients with aortic anatomy that have different diameters in the proximal and distal portions of the aorta.” He added, “these new sizes will be especially beneficial in the treatment of aortic dissections.

“With these additional tapered designs, we will be able to offer more sophisticated care, along with the consistent deployment of the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System. Gore has delivered again!” He concluded.

“We are very pleased to be launching these new large-diameter tapered devices in Japan as the first country in the world,” said Japan Business Leader Yasuaki Kagawa.

He continued, “In Japan's reimbursement system, there is a limit to the number of devices that can be used for each case, so the new large-diameter tapered devices, which provide more options for treatment, are also beneficial from a health economics perspective.

“Furthermore, these large-diameter tapered devices can be used in conjunction with upcoming branched devices, which were approved by the PMDA in November 2024. The new tapered devices expand the potential device fit for patients with broader pathologies.” He concluded.

Gore engineers medical devices that treat a range of cardiovascular and other health conditions. With more than 55 million medical devices implanted over the course of more than 45 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers. Gore is joined in service with clinicians and through this collaboration we are improving lives. For more information, visit goremedical.com. 

About Gore 

W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments—from outer space to the world’s highest peaks to the inner workings of the human body. With approximately 13,000 Associates and a strong, team-oriented culture, Gore generates annual revenues of $5 billion.  
gore.com

Media Contact 

Isabella Wong 
Goremedicalmedia@wlgore.com
 

For complete indications and other important safety information for Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU).

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