Lifetech's Absorbable Drug-Eluting Peripheral Stent System Completes First U.S. Implantation

SHENZHEN, China, July 28, 2021 /PRNewswire/ -- On July 21, 2021, at the University of Arizona Health Sciences Center in Tucson, USA, the innovative bioresorbable drug-eluting peripheral stent system ("IBS Titan™"), independently developed by Biotyx Medical (Shenzhen) Co., Ltd. ("Biotyx Medical"), a controlling subsidiary of Lifetech Scientific (01302.HK), completed its first implantation in the United States. Approved under the U.S. FDA's "Compassionate Use" program, this is the third innovative product from Lifetech Scientific to receive such approval.

Undergo this procedureThe patient's left distal popliteal artery was severely occluded, leading to tissue ulceration and necrosis in the left leg, accompanied by severe pain, lower extremity numbness, coldness, and other symptoms. Due to the impact of previous surgical interventions, the patient had no autologous vessels available for bypass grafting, and other conventional treatment regimens previously attempted had failed to yield significant improvement, placing the patient at a high risk of amputation. Stent implantation may be the patient'sRelatively satisfactoryFor the treatment approach, currently, the only products available in the North American market suitable for the diameter of the patient's diseased vessel are coronary stents; their length is insufficient to meet the lesion coverage requirements of the patient's left infrapopliteal artery, and permanent stent implantation may lead to a series of issues, such as the difficulty of performing reintervention on the vessel in the event of restenosis.

IBS Titan™ is specifically developed for infrapopliteal arterial lesions, intended to improve the lumen diameter of infrapopliteal vessels in patients requiring stent therapy, and isWorld's FirstA fully bioresorbable peripheral vascular stent with an iron-based main structure. The scaffold is fabricated from a high-strength nitrided iron tube and integrated with a specialized coating design to regulate the stent's degradation rate. Additionally, the stent utilizes a poly(lactic acid) (PLA) coating for the controlled release of sirolimus, effectively inhibiting the proliferation and migration of smooth muscle cells.

Based on currently available data, the mechanical properties and clinical handling performance of the IBS Titan™ are comparable to those of mainstream cobalt-chromium alloy permanent stents on the market. Furthermore, it features a thinner wall thickness and a more comprehensive range of specifications compared to currently marketed below-the-knee peripheral stents. With a maximum length of 118 mm, the stent can easily navigate into diseased vessels for recanalization and enables the treatment of stenotic lesions up to 200 mm in length through stent overlapping. Consequently, the IBS Titan™ is well-suited for treating long-segment, diffuse calcified lesions, significantly improving vessel patency rates. At the same time, it circumvents the drawbacks associated with balloon angioplasty, such as suboptimal mid- to long-term patency, as well as the limitations of permanent stents, including restricted size availability and the difficulty of reintervention following restenosis.

After thoroughly evaluating the patient's condition and confirming that the IBS Titan™ is available in specifications suitable for the patient's target treatment vessel, and that it possesses mechanical properties non-inferior to permanent stents along with the fully degradable characteristic of "intervention without implantation," the attending physician applied to the U.S. FDA for "Compassionate Use," which was formally approved on July 14, 2021.

On July 21 local time, the procedure was successfully performed at the University of Arizona Health Sciences Center in Tucson, USA, during which a bioresorbable drug-eluting peripheral stent was successfully implanted into the patient's left below-knee popliteal artery. This marks the first below-knee popliteal artery stenting procedure in the United States utilizing the IBS Titan™. The patient has since been successfully discharged.

IBS Titan™ is one of the core products on Lifetech Scientific’s globally pioneering iron-based bioresorbable material platform. It is also another independently developed, first-in-class product approved by the US FDA for "Compassionate Use," following another core product on this platform—the IBS Angel™ iron-based bioresorbable stent system. The successful implantation in the United States fully demonstrates the recognition by clinical experts in the core North American market of the technological advantages of this innovative product. Currently, IBS Titan™ is undergoing clinical studies for regulatory registration in China to obtain more evidence-based clinical data to further verify its safety and efficacy. Upon successful market launch, it will deliver tangible benefits to a broad population of patients with infrapopliteal vascular diseases.