Shape Memory Medical has concluded subject enrolment in the AAA-SHAPE early feasibility trial of the IMPEDE-FX RapidFill Device.
The prospective, multicentre safety study has been designed to evaluate the use of the device for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR).
The device includes a shape memory polymer, which is a porous embolic material that self-expands when it comes in contact with blood.
It is said to be the first prospective clinical study to assess the material’s application in AAA participants and its potential to improve aneurysm sac regression rates after EVAR.
The study has enrolled a total of 35 participants at two New Zealand sites and three locations in the Netherlands. The follow up for the participants will be over two years.
Shape Memory Medical president and CEO Ted Ruppel said: “We are pleased to reach this critical milestone in our AAA-SHAPE clinical programme.
“We would like to thank the patients, investigators and clinical study teams for their important contributions, and we look forward to evaluating the follow-up data to come.”
The IMPEDE-FX RapidFill Device has been designed to obstruct or reduce the blood flow rate in peripheral vessels.
The device has five IMPEDE-FX 12mm embolisation plugs preloaded in a single delivery introducer, which enables the delivery of multiple embolisation plugs in a single application.
This helps with the quick filling and occluding of large vessels or lesions in cases when lower fluoroscopy or procedure times, blood loss and contrast media are needed.
In 2019, Shape Memory Medical obtained CE mark for the TrelliX Embolic Coil System, which helps obstruct blood flow in vascular abnormalities of the neurovascular and peripheral vessels.