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Coding CTO DES Hypertension Imaging Modalities PCI Pharmacology Radial Regulatory Structural Disease Valvular Interventions

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Coding CTO DES Hypertension Imaging Modalities PCI Pharmacology Radial Regulatory Structural Disease Valvular Interventions

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US Company Directory


Haemonetics

125 Summer Street, Boston, MA 02110

PHONE: (781) 848-7100

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Other Devices / Closure Devices

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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

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Other Devices / Esophageal Protection for RF Cardiac Ablation

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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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Balloons Catheters Sheaths Stents Structural Heart Valves Wires Other Devices View All

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Coding CTO DES Hypertension Imaging Modalities PCI Pharmacology Radial Regulatory Structural Disease Valvular Interventions
Centers

Coding CTO DES Hypertension Imaging Modalities PCI Pharmacology Radial Regulatory Structural Disease Valvular Interventions

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Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions.



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