San Diego, United States – From September 21st to September 25th, the 30th Transcatheter Cardiovascular Therapeutics (TCT 2018) took place in San Diego, California. The TCT conference is the world’s largest and most important educational meeting specializing interventional cardiovascular medicine. Lifetech Scientific attended the conference and released the feasibility study data of the Lifetech IBS™ sirolimus-eluting iron absorbable coronary stent system.
(TCT 2018 conference)
Professor Kefei Dou from Beijing Fuwai Hospital introduced the progress and preliminary results of the IBS™ clinical studies. The aim of the study is to evaluate the feasibility, safety and effectiveness of the IBS™ with the planned 45 cases (China) and 15 cases (Malaysia). 3 years of radiography follow-up and 5 years of clinical follow-up are planned and the primary endpoints of the studies are 6 months of Target Lesion Failure (TLF) and Late Loss (LL).
(Prof. Kefei Dou, Fuwai Hospital)
As of now, 20 cases have been enrolled in Beijing Fuwai Hospital, and the 1-month follow-up of 17 cases have been completed. The average age of the enrolled patients is 52.8±1.99, the average length of the lesion vessel is 16.4±0.49 mm, the average RVD is 3.3±0.56%. The procedure success rate is 100%, and there are no complication events during the procedure.
According to the 1-month follow-up data, there is no occurrence of TLF (including cardiac death, TV-MI and CT-TLR) and related composite endpoints (including all-cause mortality, MI and revascularization due to any reason). There is also no formation of thrombus or any device related serious adverse events happening.
Professor Dou also shared the 6-months follow-up results of the first implantation of IBS around the world, which was done during the CIT conference on March 23rd, 2018. The radiography follow-up results showed high patency of vessels. The OCT results of the 6-months follow up showed complete strut apposition as well as 100% struts coverage with a mean thickness of strut coverage of 0.10±0.05. The early outcomes of the study are encouraging, with the IBS™ scaffold being comparable with current permanent stents in terms of specifications, indications and clinical operation. Long-term and expanded data are needed, and Lifetech Scientific will continue focusing on determination of the safety and the efficacy of IBS™.
(6-months follow-up results of the IBS™)
About Lifetech IBS™ sirolimus-eluting iron absorbable coronary stent system - The IBS™ sirolimus-eluting iron absorbable coronary stent system developed by LifeTech is currently the only absorbable stent that is comparable to permanent stents in performance and the range of specifications. The scaffold, only 50–55 μm thick, weighs 2.6–23 mg for the entire range of available specifications, which is much less than the daily iron dosage transferred by hemoglobin in an adult blood system. The novel design of a zinc barrier layer makes it possible for the IBS scaffold to have ultrathin struts and thick PDLLA coating of 12 μm to maintain adequate scaffolding after implantation while having a significantly shortened corrosion period.