New Fully Absorbable Patch Based Large Hole Vascular Closure Device
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1 New Fully Absorbable Patch Based Large Hole Vascular Closure Device Jeffrey J. Popma, MD Beth Israel Deaconess Medical Center, Boston, MA
2 Disclosure Statement of Financial Interest Over the past year, I have received the following: Institutional Grants: Medtronic, Boston Scientific, Abbott Vascular, Edwards, Cook Medical Advisory Board: Boston Scientific Consultant: Cordis, Edwards 1
3 Drivers of Clinical Need in Large Bore Vascular Closure Desired Approach: Fully percutaneous Easy to use Safe and secure TAVR EVAR TEVAR ECMO Fully bioabsorbable Challenge: 1-5% complications associated with currently available large hole closure
4 PerQseal Designed for large arteriotomies External Locator Scaffold Simple OTW operation All components fully absorbable from same synthetic polymer Seals from inside Up to 24F holes No suture, collagen or metal components Patch Day 1 Day 180
5 PerQseal Three Step Device Deployment Loading cannula connect to the introducer hub Device handle connects with the introducer hub forming an integrated unit Sheath actuator is rotated 180 degree clockwise releasing the outer sheath and exposing the implant patch Delivery system is retracted until the patch contacts the arterial wall Guidewire removed Release actuator rotated 180 degree clockwise External locator secures implant
6 Pre-Clinical Gross Pathology Porcine abdominal aorta 32 Day post implantation 91 Day post implantation Implant Endoluminal coverage of the implant by mature, stable and generally endothelialized neointima Implant patch absorbed, foot section migrated extra- arterial and absorbing
7 Pre-Clinical Histology days post implantation Implant Encapsulated Implant absorbing and extra-arterial Implant Absorbed 32 days 91 days 180 days Porcine abdominal aorta luminal surface 162 days post implantation Implantation site 22F Arteriotomy Complete absorption Longitudinal 162 days Implantation site undifferentiated from native arterial wall No granuloma/scaring No perivascular fibrosis
8 Clinical Experience 77 year old Male, Ht. 175 cm, Wt. 63 kg Med: 15 mg q.d. rivaroxaban TAVR Edwards 16F SAPIEN 3 29mm valve Closure Vivasure PerQseal Dr Peter Crean, St. James Hospital, Dublin, Ireland
9 Clinical Program Study Type # sites # Cases TAVR: EVAR:TEVAR Frontier I* FIM :2:0 Frontier II* CE Mark :20:1 Frontier III* CE Mark :16:4 Enrolling Frontier IV Indication Expansion On-going Planned Registry Post market US IDE US approval * No acute major device related vascular complications * No late major or minor device related vascular complications
10 Overall Clinical Experience Over 120 patents implanted (9 centres across EU) TAVR EVAR TEVAR No major VARC-II vascular complications (no roll ins) Follow up assessments completed (30d, 90d, 1yr) No late major or minor device related vascular complications No clinically significant stenosis, turbulence, aneurysm formation on follow-up Ultrasound scans CE Mark
11 Clinical Experience Vessel patency post-implantation Pre-implantation Peri-procedure tamponade < 15 min. Post-implantation Implant Implant Delivery shaft Low profile, non-stenosing absorbable implant
12 Clinical Experience Pre-procedure 1 mo. Post-procedure
13 Clinical Experience EVAR - bilateral arteriotomy closures Pre-Implantation 2 days Post Implantation
14 Technology Development PerQseal EVAR PFO TMVR LAA VAD TAVR BAV TEVAR
15 PerQseal Summary Easy to use device with low learning curve Patch-based, fully absorbable implant Requires no pre-procedure steps Has clinically demonstrated its safety and effectiveness with excellent outcomes from discharge through 12 month follow-up (>120 patients in Frontier studies) Device provides a real option for fully percutaneous closure with the potential to reduce hospital costs and procedure times Proprietary polymer technology promising in expanded vascular indications
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BASELINE CHARACTERISTICS. Patients (n) 62. Age (years) 77.6 ± 7.4. Male gender (%) 59.7% Weight (kg) 81.7 ± 17.4
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Pipeline Embolization Device The power to redefine aneurysm treatment. REDEFINE The Pipeline device redefines treatment for large or giant wide-necked aneurysms by reconstructing the parent artery and