Nectero Medical today announced that the US Food and Drug Administration (FDA) has granted investigational new drug (IND) clearance for the company to initiate a prospective, multicentre, randomised clinical trial (the stAAAble study) to evaluate the safety and efficacy of the Nectero endovascular aneurysm stabilisation treatment (EAST) system in patients with infrarenal abdominal aortic aneurysms (AAAs), maximum diameter 3.5–5cm.
“We believe the Nectero EAST system has the potential to address a significant unmet clinical need and improve outcomes in AAA patients who currently have no proven treatment options. Nectero EAST aims to be the first therapy to stabilise growth of small- to mid-sized AAAs,” commented Jack Springer, president and chief executive officer of Nectero Medical. “The IND clearance and initiation of a landmark pivotal study reflect our continuing commitment to bringing transformative therapies to improve the lives of patients with aneurysmal disease.”
The Nectero EAST system is a single-use, endovascular system for the treatment of infrarenal AAAs and is comprised of a dual-balloon delivery catheter and stabiliser mixture containing pentagalloyl glucose (PGG). The system delivers PGG locally into the aneurysmal wall where it binds to elastin and collagen to strengthen the aortic vessel wall and potentially reduce the risk of further degradation. A press release details that the procedure does not require any specialised tools or training, takes less than an hour to complete, leaves no permanent implant behind and does not preclude any future interventions.
“I am really encouraged by the initial data of the Nectero EAST system to potentially slow the growth of AAA and thereby minimise the likelihood of rupture and/or need for major intervention,” commented Dan Clair (Vanderbilt University Medical Center, Nashville, USA), co-principal investigator for the stAAAble study. “If proven safe and efficacious at stabilising AAA growth, the Nectero EAST system has the potential to transform the lives of thousands of patients with aneurysmal disease. We are honoured to be one of the centre to participate in this groundbreaking study that is likely to have a pronounced impact on the future management of AAA patients.”
The IND submission was supported by a prospective, first-in-human study of 21 patients treated outside the USA. Early Phase I clinical results were recently published in the Journal of Vascular Surgery and showed that a single, localised PGG administration to patients with small- to medium-sized infrarenal AAAs was safe and demonstrated the potential to slow the growth of AAA. The stAAAble study will be conducted largely in the USA and is expected to initiate enrolment in the next few months.