EndoNom Medtech Successfully Completes World's First Clinical Implantation of Modular Embedded Aortic Arch Stent-Graft System

Beijing, July 10, 2019 /PRNewswire/ -- On June 25, 2019, the world’s first clinical implantation of the “Modular Embedded Aortic Arch Stent Graft,” innovatively developed by Hangzhou Wei Qiang Medical Technology Co., Ltd. (hereinafter referred to as “Wei Qiang Medical”), a subsidiary of Deno, was successfully performed at the Chinese PLA General Hospital. The procedure was carried out by a surgical team led by Professor Guo Wei, Director of the Department of Vascular Surgery at the First Medical Center of the Chinese PLA General Hospital. The case was also presented on June 25 (U.S. local time) at the 15th Annual C3 Conference (Complex Cardiovascular Catheter Therapeutics) in the United States.Innovative Design, Major Breakthrough, Perfect OutcomeIt received unanimous praise and acclaim from the attending experts and scholars.

The clinical application study of the new technology for the modular endovascular aortic arch stent-graft system was approved by the Medical Ethics Committee of the Chinese PLA General Hospital in February 2019.

BackgroundInformation:

CT ExaminationPatientDiagnosed with a saccular aneurysm of the aortic arch, accompanied by hypertension and cerebrovascular disease.

Surgical Outcomes：

Intraoperatively, each module of the “modular endovascular stent graft for the aortic arch” was safely implanted; the deployment process was stable with no migration, and the modules were securely interconnected. Final angiography demonstrated complete exclusion of the aortic arch aneurysm, absence of endoleak, and patency of the main body and branch vessels.

Pre-discharge CT follow-up showed: the aortic arch aneurysm was completely excluded, the main aortic body and branch vessels were patent, there was no type I or type III endoleak of the stent graft, and the stent graft did not migrate. The patient’s vital signs were stable.

Diseases of the aortic arch have long been considered a contraindication for endovascular repair due to their complex anatomical structure, and currently, no commercially available endovascular devices worldwide are suitable for this application. The successful implementation of this procedure holds significant importance for the endovascular treatment of aortic arch diseases.

Aortic Arch Diseases:

With economic development and population aging, the incidence of aortic diseases has been rising year by year. Since Parodi et al. performed the first endovascular repair of an abdominal aortic aneurysm in 1991, the treatment of aortic aneurysmal diseases has gradually shifted from “traditional open surgery” to “minimally invasive endovascular repair.” However, existing endovascular devices, both domestically and internationally, only address simple anatomical lesions, such as thoracic aortic aneurysms and some infrarenal abdominal aortic aneurysms. For complex anatomical lesions, particularly aortic arch diseases involving multiple branch vessels, there are currently no commercially available endovascular products on the international market.

Diseases of the aortic arch include pathologies such as true aneurysms, pseudoaneurysms, and dissecting aneurysms involving the aortic arch. The incidence of arch diseases is relatively high; for instance, Type A aortic dissection (involving the aortic arch and ascending aorta) occurs two to three times more frequently than Type B dissection. The anatomy of the aortic arch is complex: the main vessel of the arch exhibits a curved morphology and serves as the primary conduit for blood supply to the visceral organs and lower extremities; the branch vessels arising from the arch are critical for maintaining perfusion to the brain and upper limbs, with significant inter-individual variability in branch diameter and spacing. The primary challenge in endovascular treatment of aortic arch diseases lies in ensuring the patency of the arch branch vessels while excluding the diseased segment. Prolonged cerebral ischemia can result in fatal outcomes for patients. Currently available endovascular products on the market cannot achieve this, so surgical intervention (total arch replacement) remains the predominant treatment modality. However, total arch replacement surgery is highly complex and invasive, requiringAtCompleted under conditions of deep hypothermic cardiopulmonary bypass, with a higher incidence of postoperative complications.

Modular Embedded Stent Graft for the Aortic Arch

Wei Qiang Medical has innovatively developed this module-embedded aortic arch stent graft through medical-engineering collaboration, which includes the module-embedded aortic arch stent graft and its corresponding delivery system. The module-embedded aortic arch stent graft adopts a modular and embedded design, ensuring blood supply to the main vessel and branch vessels during the procedure while meeting the needs of clinical individualization. To ensure stability during the deployment process, the delivery system for the module-embedded aortic arch stent graft incorporates advanced technologies such as precise release, post-release adjustment, and adjustable curvature release, better aligning with the product's deployment requirements.

Professor Guo Wei, Chief of the Department of Vascular Surgery at the Chinese PLA General Hospital and the principal investigator of this postoperative study, stated: “Currently, complex aortic arch diseases remain a therapeutic challenge in the field. With advancements in medical care and technological innovation, minimally invasive treatment for aortic arch diseases will become the primary direction of development in the aortic field. To achieve management of aortic arch diseasesEndoluminalMeeting Clinical Treatment Needs Must Satisfy Two Conditions: 1) Product Design Must Fully Address the Complex Anatomical Structures and Hemodynamic Requirements of the Aortic Arch; 2) The Product Operation Process Must Be Safe and Controllable, Facilitating Wider Adoption. This clinical trialPreliminary ConfirmationModular Embedded Stent Graft for the Aortic ArchThe requirements of the above two points have already been met.Future needs also includeConduct thorough validation and assessment through large-sample clinical trials.”

"Modular Endovascular Stent Graft System for the Aortic Arch"”Upon completion of the clinical trials for the new technology, further development will continue.WithAn international multicenter clinical trial led by Professor Guo Wei as the principal investigator has introduced the Chinese approach to the endovascular repair of aortic arch diseases, a global challenge.