Led by David Altschul, MD, as national co-principal investigator, Montefiore Einstein is participating in a prospective, United States (U.S.) and outside of the United States (OUS), single-arm, multicenter, interventional study to establish the safety and efficacy of the Saccular Endovascular Aneurysm Lattice (SEAL™) system for the treatment of patients with wide-necked unruptured or ruptured intracranial aneurysms (≤ 19 mm in widest diameter). The data from this study will be used to support a premarket approval (PMA) submission. 

“This is exciting as currently there is no endosaccular device approved to treat intracranial aneurysms larger than 10 mm,” says Dr. Altschul. If the trial is successful, this new device may offer an effective minimally invasive method for patients with large aneurysms that historically needed to be treated with open surgical clipping. The SEAL™ device is a promising, versatile and novel technology that has the potential to treat wide or multilobulated aneurysms of irregular shape, or aneurysms with very shallow depth, and may eliminate the need for dual antiplatelet therapy.

Over the last decade, treatment of brain aneurysms has moved away from open surgery to endovascular treatment, except for aneurysms of a particular shape, known as wide-necked bifurcation aneurysms. Before endovascular flow disruptors became available, these complex aneurysms remained a challenge to treat with catheter-based, minimally invasive techniques, as the aneurysmal opening is commonly too wide for the use of conventional coils. 

We’re ranked in the top 1% of all hospitals in the nation for neurology and neurosurgery according to U.S. News & World Report, and we are an international referral site for the most complex cases.

If you are interested in enrolling a patient in this clinical trial, please call 718-920-7476

Clinical Trial ID: NCT05831202