TT Medical Secures CE Certification for Drug-Coated Coronary Balloon, Expands Comprehensive Portfolio in Coronary Intervention

VCBeat has learned that TT Medical (TT Medical) Paclitaxel-Coated Coronary Balloon Dilatation Catheter (EverFlow®·Feiliu®) recently receivedCECertification. Dr. Wu Tiangen, founder of TT Medical, stated, “This is the fourth product certification our company has obtained this year, and it is also the first Chinese drug-coated coronary balloon to enter the international market.”

As TT Medical experienced rapid growth, we also observed significant changes in the coronary intervention market in 2020.

On November 5, the national volume-based procurement results for high-value medical consumables were announced, with the price of coronary stents dropping significantly to RMB 700. This change has prompted an increasing number of medical device companies to focus on research and development innovation, making innovative devices such as drug-coated balloons, innovative balloon catheters, and bioresorbable stents popular R&D projects.

Amid this surge of interest, TT Medical’s drug-coated balloon catheters and other innovative coronary intervention products—including next-generation bioresorbable vascular scaffolds, various functional balloon catheters, and spiral-cutting balloon catheters—have garnered significant industry attention.

TT Medical is a high-tech enterprise providing interventional treatment solutions for cardiovascular diseases, dedicated to the research, development, and manufacturing of high-end interventional devices. Its product portfolio includes metal and bioresorbable drug-eluting stents, drug-coated balloon catheters (paclitaxel and sirolimus), innovative balloon dilation catheters, spiral cutting balloon catheters, coronary microcatheters, coronary extension catheters, and intra-aortic balloon pump catheters.

Dr. Wu Tiangen told VCBeat, “The company focuses on innovation in the field of coronary intervention and has established R&D and production centers in both China and the United States. Specifically, it has built a Class 10,000 GMP production workshop in the Songshan Lake National High-Tech Industrial Development Zone in Dongguan, and a product R&D center in Boston, USA.”

TT Medical focuses on the coronary intervention market due to the large patient population and their urgent needs.

According to the "Report on Cardiovascular Health and Diseases in China 2019," there are 330 million prevalent cases of cardiovascular disease in China, including 11 million patients with coronary heart disease. In terms of mortality, cardiovascular diseases remain the leading cause of death, accounting for 45.91% and 43.56% of all deaths in rural and urban areas, respectively, which is higher than that of cancers and other diseases.

Clinically, drug-eluting stents are associated with a 10% rate of restenosis and carry a risk of late thrombosis. In contrast to drug-eluting stents, bioresorbable scaffolds completely degrade within 2–3 years after implantation and are eliminated from the body via respiration and renal excretion, thereby avoiding the risk of thrombosis. Drug-coated balloons are removed immediately after vessel dilation, requiring no permanent implantation; furthermore, stent implantation remains an option if restenosis occurs.

According to reports, the current consensus for addressing the aforementioned clinical pain points is “intervention without implantation.” Therefore, innovative devices such as bioresorbable stents and drug-coated balloons, which leave no foreign bodies in the human body after use, will have significant opportunities for development.

According to reports, TT Medical focuses on bioresorbable stents and offers a comprehensive portfolio of coronary interventional devices. Among these, its series of coronary balloon dilation catheters and paclitaxel-coated drug-coated balloons have received EU approval; while its coronary cutting balloons, extension catheters, and microcatheters are currently undergoing application for EU CE certification. The aforementioned products are in various stages of regulatory review, clinical trials, or type testing in China.

One of TT Medical’s core products is the PowerScaffold® bioresorbable vascular scaffold. Dr. Wu Tiangen stated, “The first-generation bioresorbable scaffolds, represented by Abbott’s BVS, failed to meet expected safety and efficacy standards due to inherent design and manufacturing flaws, leading to the discontinuation of BVS sales shortly after its market launch. However, the market did not disappear following the withdrawal of Abbott’s BVS; on the contrary, the industry, including Abbott itself, has been vigorously developing and deploying next-generation bioresorbable scaffolds.”

As an innovative product, the PowerScaffold® bioresorbable vascular scaffold features breakthrough innovations in material, structure, manufacturing process, and drug-coating technology. For instance, the bioresorbable scaffold is designed with a unique diamond-shaped structure, which ensures structural stability, enhances support, and simultaneously achieves a low elastic recoil rate and an extremely small crimped outer diameter.

In terms of manufacturing processes, TT Medical imparts shape-memory functionality to stent tubing through shape-memory extrusion technology, thereby enhancing the tubing’s ductility. Through innovative drug-incorporation technology, anti-restenosis drugs are integrated into the stent struts to achieve controlled drug release, minimize drug loss, and improve therapeutic efficacy. The company employs non-destructive crimping technology to ensure a small outer diameter after crimping without detachment. Furthermore, precision femtosecond laser machining is utilized for the fine fabrication of the stents.

In terms of core parameters, TT Medical’s PowerScaffold bioresorbable scaffold is in a leading position compared to the first-generation bioresorbable stents. Wu Tiangen revealed, “The company has conducted comprehensive performance testing, biocompatibility assessments, and preclinical animal studies on the PowerScaffold. The results demonstrate that the product is safe, reliable, and possesses significant clinical value. Clinical trials are currently underway, with Peking University Hospital serving as the lead institution.”

TT Medical’s other core product is the coronary drug-coated balloon, including paclitaxel- and rapamycin-eluting balloons. The paclitaxel-coated drug balloon (EverFlow®) has received EU approval and is currently in the registration application phase in China.

Currently, the primary drug used in coronary drug-coated balloons is paclitaxel. Due to issues related to dosage and toxicity, paclitaxel has consistently yielded to sirolimus-eluting stents in the field of drug-eluting stents; consequently, sirolimus-coated balloons are considered safer and more effective. However, because sirolimus is difficult to coat onto the balloon surface, sirolimus-coated balloons still face significant technical barriers globally.

To address this challenge, TT Medical conducted comprehensive R&D efforts across its drug-coated balloon platform, drug formulation, and coating processes, ultimately developing the SuperFlow® sirolimus-coated drug-eluting balloon. Currently, the SuperFlow® sirolimus-coated drug-eluting balloon is undergoing preclinical animal studies.

Dr. Wu Tiangen stated, “Unlike other products on the market, the EverFlow® paclitaxel-coated drug-coated balloon utilizes specialized drug-loading balloon technology and an innovative spraying technique to achieve 100% drug coverage on the balloon surface, minimize drug loss during delivery, and enhance drug release and absorption efficiency. In terms of manufacturing, TT Medical’s drug-coated balloons feature a smaller outer diameter, ensuring excellent trackability, while compliance and burst pressure are optimally optimized.”

In addition, TT Medical has developed distinct products targeting different types of coronary artery obstructions. For atherosclerotic lesions, it offers the spiral drug-coated balloon (VesSpiral®), which recanalizes vessels via a spiral mechanism. For sclerotic or calcified plaques, it provides the coronary spiral cutting drug-coated balloon (VesSculpt®), which clears vascular occlusions by micro-incising plaques with rotating microscopic blades.

Furthermore, TT Medical has developed the Rotablator® rotational atherectomy catheter for totally occluded lesions; coronary extension catheters for distal lesions; coronary microcatheters for small vessel disease; coronary thrombectomy catheters for coronary thrombosis; and intra-aortic balloon pump (IABP) catheters for emergency treatment of patients with acute myocardial infarction.

Dr. Wu Tiangen stated, “The comprehensive portfolio of coronary intervention products is designed to enable clinicians to select the most appropriate interventional devices for diverse clinical conditions.”

In addition to coronary intervention products, TT Medical leverages its robust R&D and innovation capabilities to collaborate with other enterprises in the joint development of additional interventional devices. In the cerebrovascular field, it has signed an agreement with Zhuhai Niwan Medical to co-develop cerebrovascular interventional devices. In the peripheral vascular field, it is in negotiations with a medical device company in Suzhou to jointly develop peripheral vascular interventional devices. In the gastrointestinal tract domain, its independently developed three-stage balloon dilation catheter (MultiStage®) has gained wide market acceptance and is now being mass-marketed both domestically and internationally. In the respiratory field, the multi-lumen intracorporeal lung membrane oxygenation balloon dilation catheter (ICOMB®), developed for emergency treatment of patients with COVID-19, has entered the regulatory registration process both in China and abroad.

“We are from Boston, but we surpass Boston in technology. Our long-term development goal is to build an international group specializing in interventional medical devices,” Wu Tiangen told VCBeat.

Innovation is the core competitiveness of TT Medical. The company’s product portfolio demonstrates that it is an R&D-driven enterprise, with outstanding research and development capabilities and innovative strength.

Unlike importing foreign technologies or imitating imported products, TT Medical focuses on independent research and development, aiming to create new products through pioneering technologies, which requires exceptional R&D capabilities and innovation.

Dr. Wu Tiangen stated, “From its inception, the company has been committed to a path of innovation.” TT Medical boasts an international innovation team whose core members hail from prestigious institutions such as Harvard University, the University of Massachusetts, Peking University, and Wuhan University. The team was honored with the title of “Leading Team for Innovation and Entrepreneurship under the Guangdong Pearl River Talent Program” in 2015. The team comprises internationally renowned experts in polymer materials and engineering, as well as clinical medicine specialists from Harvard and Peking University. Led by Dr. Wu Tiangen, an expert in the interdisciplinary field of medicine and polymer materials, the team benefits from complementary knowledge structures that foster innovation.

In addition to its outstanding R&D team, TT Medical has established strategic partnerships with renowned universities such as Harvard University, the University of Massachusetts, Peking University, and Wuhan University to jointly develop products and cultivate talent.

Finally, Dr. Wu Tiangen told VCBeat: “TT Medical is currently undertaking a new round of financing, with the funds primarily allocated to market expansion, scaling up production of marketed products, and research and development of new products.”