Osaka Medical College, Fukui Tateami Co., Ltd. and Teijin Limited announced that they have completed their registration of registered their targeted number of subjects for an ongoing clinical trial of the OFT-G1 (provisional name) patch for cardiovascular surgery. Participants, who are targeted for participation in a clinical trial that has been under way since May 2019, are patients ranging from infants to adults who are suffering from various congenital heart diseases. Osaka Medical College, Fukui Tateami and Teijin aim to apply for approval to manufacture and market their cardiovascular patch after evaluating safety and efficacy data covering the one-year periods after each subject undergoes surgery using the OFT-G1 patch.
The OFT-G1 features a revolutionary design incorporating the Osaka Medical College’s expertise in cardiovascular surgery, Fukui Tateami’s pioneering warp-knitting technology and Teijin’s advanced polymer-application technology. Development was supported by a special program launched in 2017 by the Japan Agency for Medical Research and Development (AMED) to facilitate collaboration between medical academia and industry.
Also, in April 2018, the Ministry of Health, Labor and Welfare designated the OFT-G1 as a “SAKIGAKE” product qualifying for various incentives to speed up its approval for clinical use.
Treatments have been devised to improve the long-term survival of patients who undergo cardiovascular surgeries for purposes such as replacing defective heart tissue or enlarging narrowed blood vessels (stenosis). Demands are growing for increasingly advanced treatments that are less likely to cause tenosis due to the patient’s somatic (physical) growth in areas where patches have been implanted and reoperations due to patch deterioration or calcification after long-term implantation.
The OFT-G1’s absorbable portion is naturally replaced with the patients’ own tissue after implantation. Also, its strong but expandable structure allows it to conform to the patient’s somatic growth. Accordingly, the OFT-G1 is expected to alleviate physical,mental or financial burdens that patients and their families may experience in regard to possible corrective surgeries.
Going forward, Osaka Medical College, Fukui Tateami and Teijin will continue with clinical trials to confirm the clinical effectiveness and safety of the OFT-G1 cardiovascular patch, and thereafter work toward approval as quickly as possible in Japan and then other countries worldwide. Simultaneously, they will continue with product development efforts aimed at enhancing the quality of life for patients with
cardiovascular diseases.