Your Expert Partner for Specialty Sheaths Specialty Sheath
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Your Expert Partner for Specialty Sheaths
Specialty Sheath Experts Leading outsourcing partner for MI delivery & access devices including specialty sheaths Services provided: • Custom sheath design • Manufacture to finished packaged product • Vertically integrated supply chain • Regulatory submission & approval Specialize in custom sheaths for: • Structural Heart Therapies • Electrophysiology • Endovascular • Large-bore access >12 F Design solutions to address your clinical challenges 2 Confidential & Proprietary. Do not reproduce or distribute.
Portfolio Examples Structural Heart • Transfemoral access sheaths & dilators, TAVI • Sheath design & assembly to legal manufacture Therapies • • TAVI, TMV LVAD A Fib Left heart access Leadless CRM AAA/TAA Hepatic shunt • Transapical TAVI access & delivery sheath, TAVI • Curved sheath, coronary sinus access & delivery, LVAD Electrophysiology/CRM • Steerable sheath, left ventricle access & ablation delivery, A Fib • Access & device delivery sheath, leadless pacemaker • Transseptal sheath & needle, left heart access Endovascular • Large bore vascular special access • AAA/TAA Stent graft delivery sheaths, AAA/TAA • Special access & delivery sheath, hepatic shunt 3 Confidential & Proprietary. Do not reproduce or distribute. Special Access • Radial • Femoral & contralateral • Large-bore • Apical • Steerable
Complete solutions for your sheath Valve optimization • Maintain effective hemostasis Optimize sheath performance • Custom valve design - large Ø, silicone disc integration, facilitate multiple device exchanges • Effective valve aspiration, reduce embolism potential • Low profile sheath walls • Unique designs to balance flex & kink • Flow rate optimization & perfusion features Precision Navigation • Curved sheaths & dilators • Steering mechanisms • Custom proximal features Maximize ease of use • Ergonomic hub & handle design • Enhanced visibility – marker bands & fillers Lower insertion forces • Sheath/dilator coating 4 Confidential & Proprietary. Do not reproduce or distribute. Minimize vessel trauma • Atraumatic tip design & low profile solutions • Custom dilators, optimal sheath transition
Getting your sheath to market We deliver a packaged sterile device • Full spectrum services & technologies to deliver finished, packaged & sterile specialty sheath • 100 design engineers, extensive sheath knowledge including optimization of relationship between therapeutic device and introducer sheath • Vertical integration to deliver a cost effective, quality product We generate IP • We generate IP, you own it We achieve your approval • We can achieve regulatory approval of your sheath • Legal manufacturer status for several specialty sheaths, branded by customer • Decouple sheath approval from therapeutic device approval • Increase overall speed to market for new product categories • Minimize dual impact of potential regulatory hurdles 5 Confidential & Proprietary. Do not reproduce or distribute.
Formula for success • You stay focused on therapeutic device. • We deliver an approved custom sheath to market on your behalf. • Together, we get winning products to market faster. 6 Confidential & Proprietary. Do not reproduce or distribute.
Large-Bore Sheaths Specialist expertise in custom large-bore sheaths from 12 F We understand the unique challenges in large-bore sheath design 7 Confidential & Proprietary. Do not reproduce or distribute.
8 Confidential & Proprietary. Do not reproduce or distribute.
9 Confidential & Proprietary. Do not reproduce or distribute.
10 Confidential & Proprietary. Do not reproduce or distribute.
The world’s leading medical technology brands depend on us � 11 Confidential & Proprietary. Do not reproduce or distribute.
