Intratech Medical has announced the successful enrolment of two patients in a multicentre first-in-human study to assess the safety and technical performance of the Booster spiral balloon therapy for the treatment of acute myocardial infarction (AMI).
According to a press release from Intratech Medical, the study is the first ever to assess the treatment of AMI using a spiral design balloon intended to minimise infarct size growth, by elevating pressure in the heart’s vasculature.
Immediately following the revascularisation of the clogged artery, the proprietary Booster balloon is placed in the coronary sinus. Due to its spiral design, the Booster balloon causes temporary restriction of blood outflow, which elevates the vascular pressure, without compromising the blood outflow, Intratech Medical’s press release states. This elevated pressure improves oxygen delivery to the ischemic myocardium, reducing the infarct area and ultimately improving patient outcomes.
Intratech has had promising pre-clinical results and moved to launch its first-in-human clinical trials in 2022. The company secured a major investment from a key strategic corporation in the interventional cardiology field and has a comprehensive patent family with patents granted globally.