Radiopaque Shape Memory Polymers forNeurovascular Embolotherapy Applications / This Phase I project involves a major improvement in neurovascular embolotherapy. Aneurysms contributesignificantly to annual mortality: an estimated 6.5 million people in the US (~1 in 50) have an unruptured brainaneurysm, with an annual rupture rate of about 8 to 10 in 100,000 people (about 30,000 annually in the US),with fatality in 50% of the rupture cases and an incidence of permanent neurological deficit in 66% of the survivingcases, and nearly 500,000 deaths worldwide annually. The major minimally invasive surgical intervention involves the use of metal-based embolic coils to fillaneurysms. However, metal-based coils impart major artifacts in MRI and CT imaging, and also impart abiohazard heating risk in MRI imaging, complicating critical follow-up post-surgical examinations. Radiopaque shape-memory polymers (SMPs) developed at EndoShape, Inc. were incorporated as coilsin the multi-coil MedusaTM first-generation peripheral vascular embolotherapy device. The MedusaTM device,deployed using a large 0.074" catheter, had the required fluoroscopic visibility during deployment because ofthe multiple radiopaque polymer coils traversing and emerging from the catheter simultaneously as deployed. Leveraging a decision by the FDA in 2006 to re-classify embolic coils as class II devices, the 510(k)clearance of the MedusaTM multi-coil device for peripheral vascular interventions was achieved in 2014, andopened a pathway to 510(k) clearance of next-generation neurovascular devices with radiopaque SMP coils. The radiopaque SMPs used in the MedusaTM device were not sufficiently radiopaque for single-coil devicesin the smaller coil wire diameter range that is required for neurovascular applications. Now a new radiopaquemonomer, used in combination with more efficient crosslinkers that impart required mechanical properties atlower incorporation, allowing higher incorporation levels of the radiopaque monomer, has enabled requiredradiopacity to be achieved in a wire diameter range that is estimated to be 0.010"-0.021" while retainingrequired performance properties, biodurability and biocompatibility. EndoShape is on the verge of being ableto apply radiopaque SMPs to neurovascular devices with the advantages first provided to surgeons by the useof the MedusaTM device. The materials-based advantages of EndoShape SMPs obviate the disadvantages of metal coils, includingin addition to the improvements in the safety and efficacy of MRI and CT imaging in post-surgical examinationsand a reduction in surgical expense due to the lower-cost materials comprising EndoShape polymer-based coils. From 2020-2025 the total embolotherapy device market is forecasted to increase from $1.26 to $1.64 billion(+30.2%), and the market that EndoShape can address with its radiopaque polymer based SMP coils is expectedto increase from $0.89 to $1.17 billion (+31.5%); highlighting the impact EndoShape polymer-based coils arecapable of exerting in medical device markets and in improved embolotherapy patient care.
Public Health Relevance Statement: Project Narrative - EndoShape, Inc.
Embolotherapy devices are the preferred method for treating aneurysms, which now occur in about 6.5 million
people in the US. EndoShape, Inc. proposes to develop metal-free neurovascular embolic coils for neurovascular
embolotherapy procedures using unique, radiopaque shape memory polymer (SMP) technology. Unlike current
metal-based coils, EndoShape's polymer based SMPs produce coils that do not impart severe MRI and CT
imaging artifacts, or impart bio-hazard heating risks during MRI imaging, making it the first device of its kind to
enable improved critical post-surgical imaging and monitoring.
Project Terms: Aneurysm ; Blood Vessels ; vascular ; High Pressure Liquid Chromatography ; HPLC ; High Performance Liquid Chromatography ; High Speed Liquid Chromatography ; Cessation of life ; Death ; Disadvantaged ; Therapeutic Embolization ; Embolization Therapy ; Embolotherapy ; embolization ; Fluoroscopy ; Patient Care ; Patient Care Delivery ; Heating ; Hydrogen Peroxide ; H2O2 ; Hydroperoxide ; Hydrolysis ; In Vitro ; Incidence ; Iodine ; Isopropanol ; 2-Propanol ; Isopropyl Alcohol ; Rubbing Alcohol ; Magnetic Resonance Imaging ; MR Imaging ; MR Tomography ; MRI ; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance ; NMR Imaging ; NMR Tomography ; Nuclear Magnetic Resonance Imaging ; Zeugmatography ; Medical Device ; Memory ; Metals ; Methods ; mortality ; oxidation ; Platinum ; Platinum Black ; Pt element ; Polymers ; Risk ; Safety ; Stainless Steel ; Technology ; Testing ; X-Ray Computed Tomography ; CAT scan ; CT X Ray ; CT Xray ; CT imaging ; CT scan ; Computed Tomography ; Tomodensitometry ; X-Ray CAT Scan ; X-Ray Computerized Tomography ; Xray CAT scan ; Xray Computed Tomography ; Xray computerized tomography ; catscan ; computed axial tomography ; computer tomography ; computerized axial tomography ; computerized tomography ; Vacuum ; Weight ; Biohazardous Substance ; Biohazard ; Generations ; Morphologic artifacts ; Artifacts ; Catheters ; base ; density ; improved ; Procedures ; cytotoxicity test ; Peripheral ; Phase ; Variant ; Variation ; Evaluation ; Recovery ; radiologist ; Shapes ; Research Specimen ; Specimen ; Hour ; Side ; Neurologic Deficit ; Operative Procedures ; Surgical ; Surgical Interventions ; Surgical Procedure ; surgery ; Operative Surgical Procedures ; Surgeon ; biocompatibility ; biomaterial compatibility ; experience ; monomer ; Performance ; c new ; Devices ; Brain Aneurysms ; Property ; C10 ; Intervention Strategies ; interventional strategy ; Intervention ; intra-operative imaging ; intraoperative imaging ; surgical imaging ; Image-Guided Surgery ; Phosphate Buffer ; Thickness ; Thick ; Diameter ; Caliber ; Address ; Crosslinker ; in vitro Model ; in vivo ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Monitor ; follow-up ; Active Follow-up ; active followup ; follow up ; followed up ; followup ; Image ; imaging ; Pathway interactions ; pathway ; cost ; next generation ; Rupture ; minimally invasive ; arm ; Formulation ; neurovascular ; neuro-vascular ; mechanical properties ;
