WUXI, China, March 8, 2024 /PRNewswire/ — Silk Road Medical (NASDAQ: SILK), a medical device company based in California USA and Genesis MedTech Group have signed an exclusive distribution agreement to introduce the TCAR® core products, ENROUTE® Transcarotid Neuroprotection System and ENROUTE® Transcarotid Stent System, in China. TCAR (Transcarotid Artery Revascularization) is an innovative minimally invasive surgical procedure used to treat carotid artery disease, a condition characterized by the narrowing or blockage of the carotid arteries in the neck. This narrowing or blockage can restrict blood flow to the brain and increase the risk of stroke.
Since its establishment in 2019, Genesis MedTech Group has continuously strived to enhance its peripheral interventional portfolio, offering comprehensive solutions to both physicians and patients. Through its commercial team and distribution network, patients in China will now have access to the core TCAR products, the ENROUTE® Neuroprotection System and Stent Delivery System. TCAR has shown to reduce the risk of stroke, death, myocardial infraction (MI), and Cranial Nerve Injury (CNI). It is a less invasive procedure with lower rates of procedural complications and an overall improvement in outcomes, contributing to a positive impact on healthcare.
Carotid artery disease often occurs in the middle-aged and elderly population, especially among those with atherosclerosis. The condition is characterized by the buildup of plaque, and over time can cause narrowing or blockage of the carotid arteries, affecting blood supply to the brain and leading to diseases such as ischemic stroke. In recent years, stroke has become the second leading cause of mortality worldwide. In China, it now ranks as the primary cause of death and disability. Each year, over 17 million strokes affect individuals over 40 years old. Notably, around one third of ischemic strokes are caused by carotid artery disease.
In the United States, TCAR is rapidly replacing traditional procedures. As of the end of 2023, over 85,000 TCAR procedures have been performed. Before the introduction of TCAR, moderate to severe carotid artery disease was generally treated clinically with two surgical methods: Carotid Endarterectomy (CEA) and Transfemoral Carotid Artery Stenting (TFCAS). However, CEA involves a large incision and carries a higher risk of complications, posing a risk of damage to the cranial nerves of patients. Studies have also shown a higher risk of stroke during TFCAS as compared to TCAR and CEA. Based on clinical studies, TCAR is an advancement in the management of carotid artery disease.
Professor Chen Zhong, Chairman, Vascular Surgery Group of Chinese Medical Association, President, Vascular Surgery Physicians Branch of Chinese Medical Doctor Association and Chief Physician, Vascular Surgery at Beijing Anzhen Hospital, commented, "There is considerable evidence showing that TCAR offers advantages for patients with symptomatic carotid artery stenosis or those at anatomical or surgical risk."
Silk Road Medical’s CEO, Chas McKhann stated, "This agreement represents a promising initial step towards expanding the reach of the TCAR therapy with the offering of our ENROUTE Neuroprotection System and Stent Delivery System to more patients worldwide, including those in China. We are very pleased to have partnered with Genesis MedTech, a respected leader in medtech, who shares our vision for the potential impact of TCAR in preventing strokes."
"Enabling TCAR to be made accessible to the patients in China certainly marks another milestone in our efforts to bring innovative treatments to our patients. Together with Silk Road Medical, we remain dedicated to make better healthcare more accessible, improving patient care and outcomes." shared Warren Wang, Genesis MedTech Group’s Chairman and CEO.
ABOUT GENESIS MEDTECH
Genesis MedTech Group is a medical device company headquartered in Singapore. Founded by a group of professionals and entrepreneurs with MedTech experience globally, the company’s product portfolio focuses on multi-therapy medical device products for emerging markets with sales and distribution through its established commercial network. Genesis MedTech Group covers the entire industry value chain of research and development, production, quality management, supply chain, marketing, and sales.
For more information, visit http://www.genesismedtech.com
ABOUT SILK ROAD MEDICAL and TCAR
Silk Road Medical, Inc. (NASDAQ: SILK), is a medical device company located in Sunnyvale, California, and Plymouth, Minnesota, that is focused on reducing the risk of stroke and its devastating impact. The company has pioneered a new approach for the treatment of carotid artery disease called TransCarotid Artery Revascularization (TCAR). TCAR is a clinically proven procedure combining surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke. For more information on how Silk Road Medical is delivering brighter patient outcomes through brighter clinical thinking, visit www.silkroadmed.com and connect on Twitter, LinkedIn and Facebook.
References
Ramsay, I et al. Perioperative Outcomes in Transcarotid Artery Revascularization Versus Carotid Endarterectomy or Stenting Nationwide. Operative Neurosurgery 2023, 25(5):453-460.
Wang Longde, Writing Group of the China Stroke Prevention and Treatment Report 2020. Summary of the China Stroke Prevention and Treatment Report 2020[J]. Chinese Journal of Cerebrovascular Diseases, 2022, 19(2):136-144.
Vascular Surgery Group of the Chinese Medical Association Surgical Branch. Diagnosis and Treatment Guidelines for Carotid Artery Stenosis[J]. Chinese Journal of Vascular Surgery (Electronic Edition), 2017, 2(003):169-175. DOI:10.3760.cma.j.issn.2096-1863.2017.02.003
So K, Kashyap V S, Vikram, et al. (2021). Outcomes in 1-year Cohort After Transcarotid Artery Revascularization in the ROADSTER2 Trial. Journal of Vascular Surgery. 74. e383-e384. 10.1016/j.jvs.2021.07.161
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