LifeTech Scientific Announces IBS Angel™ Iron-Based Bioresorbable Scaffold Receives CE MDR Certification

ShenzhenMarch 9, 2023PR Newswire -- Lifetech Scientific (Shenzhen) Co., LTD. announced that IBS Angel,自主研发的, from its holding subsidiary Biotyx Medical (Shenzhen) Co., Ltd.^™The iron-based bioresorbable scaffold system ("IBS Angel™") has successfully obtained the EU CE MDR certification, becomingThe World's FirstThe iron-based bioresorbable scaffold system successfully commercialized in the EU. This productWorld's FirstThe product is used for minimally invasive surgical treatment of congenital heart disease (cyanotic congenital heart disease), providing children with congenital heart disease a new, safer, and more effective minimally invasive surgical treatment solution through revolutionary innovative technology.

Technological Innovation Benefits Children

Cyanotic congenital heart disease is a severe cardiopulmonary condition that poses a significant threat to the life and health of pediatric patients. Without timely intervention, these patients face imminent life-threatening risks. Currently, clinical treatment primarily involves palliative surgical procedures such as the Blalock-Taussig (B-T) shunt, followed by corrective cardiac surgery once the patient has grown sufficiently. As this approach requires at least one open-heart surgery, it imposes considerable surgical trauma on the child and carries an extremely high risk. Therefore, minimally invasive treatments like arterial duct stenting have become a new direction actively explored in recent years. This procedure involves implanting a stent into the patient's arterial duct via catheterization to maintain pulmonary blood flow. Compared with traditional open-heart surgery, this method offers advantages such as fewer side effects, higher effectiveness, shorter operation time, less trauma to the patient, and simplifies subsequent corrective surgeries. Due to the previous lack of commercially available dedicated stents, permanent stents are often used clinically. However, this frequently leads to complications during secondary corrective heart surgeries since the permanent stent becomes fully endothelialized, making its removal time-consuming and causing damage to the patient’s pulmonary artery and aorta, thus increasing the difficulty of later surgical repair.

The biodegradable property of IBS Angel™ fundamentally resolves the aforementioned issues. Its substrate is crafted from high-strength and highly ductile high-purity nitrided iron tubing, which allows for a thin stent wall with strong support. Additionally, the product is compatible with a 4F sheath (inner diameter approximately 1.35 mm), making it especially suitable for the small blood vessels of newborns and infants. After implantation of the IBS Angel™, there is no need to remove it during subsequent surgical repair procedures. Clinical trial results have shown that some patients experienced good right heart development after implantation of the IBS Angel™, with the ductus arteriosus closing automatically as the stent degrades, eliminating the need for later cardiac surgery. This means that pediatric patients only require a single minimally invasive procedure and can avoid the significant trauma caused by two surgeries, providing an ideal treatment solution for young infants, particularly those who cannot tolerate open-heart surgery.

Successful application of IBS Angel(TM) for arterial duct opening. Immediate postoperative follow-up results showed good stent morphology and unobstructed blood flow within the patient's arterial duct.

IBS Angel™ is one of the core products on Lifetech Scientific's iron-based bioresorbable materials platform. It has been implanted in multiple cases in the United States through FDA Compassionate Use approval. The product has obtained the EU CE MDR certification, further confirming the feasibility of the iron-based resorbable stent design concept and the safety of the iron-based resorbable stent series. Currently, the clinical and market access work for the three core products on Lifetech Scientific’s iron-based bioresorbable materials platform is proceeding smoothly, with the potential to bring significant changes and breakthroughs to the safe and effective treatment of related diseases worldwide in the near future.。

About Lifetech Scientific:

Lifetech Scientific (Shenzhen) Co., Ltd. (Stock Code: 1302.HK) is a leading enterprise in the field of cardiovascular, cerebrovascular, and peripheral vascular interventional medical devices. Established in Shenzhen, China in 1999, it is a national high-tech enterprise and recognized as a specialized, refined, distinctive, and innovative "little giant" enterprise by the Ministry of Industry and Information Technology of China. The company’s research and development pipeline, as well as its commercialized products, cover areas such as structural heart disease, peripheral vascular disease, pacing and electrophysiology, respiratory intervention, neurointervention, and oncology intervention, and it possessesA global firstIron-based bioabsorbable materials platform has achieved independent innovation and technological breakthroughs in multiple niche fields. As of June 30, 2022, the company has implemented a high-quality patent layout with over 1,500 patents. Currently, a total of 15 products have been approved by the National Medical Products Administration (NMPA) to enter the "Special Review Procedure for Innovative Medical Devices." Adhering to the development strategies of "innovation" and "internationalization," the company's main products on sale have long held leading market shares in China. It has subsidiaries and offices in six countries worldwide, with a sales network covering more than 100 countries and regions globally, making it one of the few highly internationalized Class III interventional medical device enterprises in China.