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| Company Name | Product Name | Diameter (inch) | Length (cm) | Coating | Tip Type | Curve Size | Comments |
|---|---|---|---|---|---|---|---|
| Haemonetics | SavvyWire | 0.035 | 280 | PTFE | Preshaped curve | X-small, small | Intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures, while measuring the pressure within the heart allowing calculation of hemodynamic parameters; additionally, the SavvyWire can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart |
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| Company Name | Product Name | Type | Puncture Size (F) | Maximum Wire Compatibility (inch) | US FDA Indicated Use | Comments |
|---|---|---|---|---|---|---|
| Haemonetics | Vascade MVP Venous Vascular Closure System (VVCS) | Extravascular, bioabsorbable closure device | 6–12 inner diameter (up to 15 maximum outer diameter) | Utilizes existing procedural sheath | Femoral venous access sites: 6 F–12 F inner diameter (up to 15 F maximum outer diameter) | Fully integrated, extravascular, bioabsorbable femoral venous closure system that is easy to use, leaves no permanent components behind, and has demonstrated safety and efficacy in the AMBULATE trial, a prospective, multicenter, randomized clinical trial comparing Vascade MVP to manual compression; system combines Cardiva’s collapsible disc technology and a thrombogenic resorbable collagen patch in an integrated design; a multiaccess site indication is required for vascular closure devices to provide hemostasis in procedures that require more than one access site in the same vessel such as cardiac ablations; Vascade MVP Venous Vascular Closure System is indicated for this use |
| Haemonetics | Vascade Vascular Closure System (VCS) | Extravascular, bioabsorbable closure device | 5, 6, 7 | Utilizes existing procedural sheath | Femoral arterial and femoral venous access sites (5 F, 6 F, or 7 F) | Fully integrated, extravascular, bioabsorbable femoral access closure system that is easy to use, leaves no permanent components behind, and has demonstrated safety and efficacy in the RESPECT trial, a prospective, multicenter, randomized clinical trial comparing Vascade to manual compression; system combines Cardiva’s collapsible disc technology and a thrombogenic resorbable collagen patch in an integrated design; it enables rapid hemostasis while minimizing complications |
| Company Name | Product Name | Type (Fixed Core/Movable Core) | Diameter (inch) | Length (cm) | Tip Type | Antithrombogenic (Yes/No) | Comments |
|---|---|---|---|---|---|---|---|
| Haemonetics | OptoWire | Nitinol core with free-floating technology | 0.014 | 175 | 0.65-g tip load | Yes | A second-generation fiber-optic pressure guidewire; accurate pressure measurements can be repeated with consistency, and fiber optic enables unique concentric guidewire design with improved torqueability; operators can access complex anatomies while saving time and cost by delivering a stent over the same guidewire; the wire is designed to provide low drift |
| Company Name | Product Name | Type | Temperature Management System Compatibility | US FDA Indicated Use |
|---|---|---|---|---|
| Haemonetics | ensoETM (models ECD01-A, ECD02-A) | Esophageal cooling device | For ECD01-A: Altrix; for ECD02-A: Blanketrol II/III | Reduce the likelihood of ablation-related esophageal injury during RF cardiac ablation procedures |
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