CryoLife, a US-based medical device and tissue processing company focused on cardiac and vascular surgery, announced that enrollment has started in the company’s BioGlue clinical trial in China. The results from the trial will serve as the basis of the company’s regulatory submission to CFDA to gain approval to commercialize BioGlue in China. Patients are currently being enrolled at multiple heart centers in China.
According to CryoLife, there are more than 40,000 aortic surgeries in China each year, which represents a significant growth opportunity for BioGlue. The company anticipates trial enrollment and follow up will take about one year, which would put CryoLife on track for potential CFDA approval of BioGlue by the end of 2019.
This clinical trial in China is a prospective, multicenter, randomized, controlled clinical investigation. The study will enroll 195 patients across seven sites. The trial will assess treatment of Chinese patients with acute type A aortic dissections with standard-of-care procedures with and without BioGlue as an adjunct for structural repair and hemostasis. The primary efficacy endpoint of the study will be successful closure of the false lumen as determined by intraoperative transesophageal echocardiography (TEE). The closure will also be measured at the time of patient discharge by computed tomography angiography (CTA).