Shape Memory Medical
Developer of endovascular embolization technologies based on shape‑memory polymer biomaterials. The company engineers catheter-deliverable, crimpable, self‑expanding porous polymer scaffolds intended to produce rapid clot formation and progressive tissue healing as the material biodegrades. Public materials describe preclinical characterization, multicenter clinical studies (early feasibility, randomized pivotal trials and post‑market registries), regulatory approvals in multiple jurisdictions, manufacturing and quality-system activities, and distributor-based commercialization in international markets.
Industries
Nr. of Employees
small (1-50)
Patents
Vascular prosthesis for leak prevention during endovascular aneurysm repair
US-12251500-B2
View DetailsVascular prosthesis for leak prevention during endovascular aneurysm repair
US-11839702-B2
View Details
Vascular prosthesis for leak prevention during endovascular aneurysm repair
US-12251500-B2
View DetailsVascular prosthesis for leak prevention during endovascular aneurysm repair
US-11839702-B2
View DetailsProducts
Volume‑expanding bioabsorbable embolic plug (shape‑memory polymer)
Catheter‑deliverable, porous, bioabsorbable embolic plug based on a shape‑memory polymer scaffold designed for high‑volume space filling, rapid clot formation and progressive tissue infiltration as material is absorbed.
Embolic coil systems incorporating porous polymer scaffold
Coil‑based embolic systems that incorporate a porous polymer scaffold to increase occlusive volume and support organized thrombus formation for neurovascular and peripheral vascular indications.
Volume‑expanding bioabsorbable embolic plug (shape‑memory polymer)
Catheter‑deliverable, porous, bioabsorbable embolic plug based on a shape‑memory polymer scaffold designed for high‑volume space filling, rapid clot formation and progressive tissue infiltration as material is absorbed.
Embolic coil systems incorporating porous polymer scaffold
Coil‑based embolic systems that incorporate a porous polymer scaffold to increase occlusive volume and support organized thrombus formation for neurovascular and peripheral vascular indications.
Services
Collaborative design and operational support for prospective multicenter randomized trials and post‑market registries to evaluate endovascular embolization therapies.
Process development, tooling, equipment qualification, validation and GMP‑compliant production support for medical device manufacture.
Commercial licensing and sublicensing of porous polymer biomaterial technology for application in adjacent therapeutic areas.
Collaborative design and operational support for prospective multicenter randomized trials and post‑market registries to evaluate endovascular embolization therapies.
Process development, tooling, equipment qualification, validation and GMP‑compliant production support for medical device manufacture.
Commercial licensing and sublicensing of porous polymer biomaterial technology for application in adjacent therapeutic areas.
Expertise Areas
- Endovascular embolization device development
- Shape‑memory polymer biomaterials engineering
- Preclinical characterization and histological assessment
- Clinical trial design and multicenter study execution (including randomized trials and registries)
Key Technologies
- Shape‑memory polymer scaffolds
- Porous biodegradable polyurethane foam matrices
- Catheter‑deliverable, self‑expanding embolic scaffolds
- Radiolucent embolic materials with low imaging artifact
News & Updates
First patient enrolled and treated at a German center as part of a multicenter post‑market surveillance registry for polymer‑based embolization plugs; registry expanded to up to ten centers in Germany with a target of treating up to 125 patients.
FDA granted an investigational device exemption (IDE) to initiate a prospective, multicenter, randomized pivotal trial evaluating sac management with polymer‑based embolic fill plus EVAR versus EVAR alone.
Announcement of completed enrollment in a prospective multicenter post‑market surveillance registry for polymer‑based embolization plugs used in peripheral embolization.
Completion of patient enrollment in a prospective multicenter early feasibility safety study evaluating a rapid‑fill embolic scaffold for abdominal aortic aneurysm sac management during EVAR; cohort follow‑up planned for two years.
Public announcements marking treatment milestones (1,500th and 3,000th patients) using the polymer‑based embolization platform.
Announcements regarding CE marking and regulatory approvals for embolization devices in multiple international markets.
First patient enrolled and treated at a German center as part of a multicenter post‑market surveillance registry for polymer‑based embolization plugs; registry expanded to up to ten centers in Germany with a target of treating up to 125 patients.
FDA granted an investigational device exemption (IDE) to initiate a prospective, multicenter, randomized pivotal trial evaluating sac management with polymer‑based embolic fill plus EVAR versus EVAR alone.
Announcement of completed enrollment in a prospective multicenter post‑market surveillance registry for polymer‑based embolization plugs used in peripheral embolization.
Completion of patient enrollment in a prospective multicenter early feasibility safety study evaluating a rapid‑fill embolic scaffold for abdominal aortic aneurysm sac management during EVAR; cohort follow‑up planned for two years.
Public announcements marking treatment milestones (1,500th and 3,000th patients) using the polymer‑based embolization platform.
Announcements regarding CE marking and regulatory approvals for embolization devices in multiple international markets.