Interventional Technologies. Nit-Occlud PDA Occlusion System

Transcription

1 Interventional Technologies Nit-Occlud PDA Occlusion System

2 The Nit-Occlud spiral coil system is designed for transcatheter occlusion of Patent Ductus Arteriosus (PDA) of all shapes. The first pfm PDA occlusion coil system was introduced in 1993 and since 2001 our 2 nd generation system Nit-Occlud is being successfully used worldwide. The Nit-Occlud PDA Device is effective and safe for occlusion of PDA s of all types up to 5 mm. Nit-Occlud Coil Nitinol coil especially designed for PDA closure Graduated stiffness from aortal to proximal windings for optimal adaptation to ductus anatomy Strong distal windings avoid pull through Tight and compact windings in the mid portion ensure fast and efficient occlusion Fits all PDA types and sizes up to 5 mm Delivery through 4F/5F Repositionable prior to release Coil is premounted on the delivery system Radiopaque MR compatible (for details, see Science Information at Disposable Delivery Handle The Nit-Occlud coil is connected to the distal end of the flexible delivery system with a patented detachment mechanism. Disposable handle for safe and easy release Delivery System is premounted on disposable handle Specification of the coil

3 Nit-Occlud Flex (4F) Flexible coil for small PDA Preloaded in a transportation sheath Ready for transfer into 4F implantation catheter Nit-Occlud Medium (5F) Reinforced coil for medium PDA Preloaded in a transportation sheath Ready for transfer into 5F implantation catheter Nit-Occlud Delivery System Precise and safe delivery of the coil Atraumatic design Radiopaque implantation catheter with gold marker Transportation Sheath The Nit-Occlud coil Flex and Medium are preloaded into the transportation sheath. For implantation the transportation sheath has to be connected to the implantation catheter (included). Protects straightened coil during delivery and storage Y-connector fixes coil in position Coil is prepared for easy transfer into introducer sheath

4 PDA Measurement To select a suitable Nit-Occlud coil the ductus type and anatomy is determined. Exact measurement is easy to carry out with the Occlu-Marker. Dimensions to be measured: D1 = Minimum Diameter D2 = Maximum Diameter L = PDA Length Coil Dimensions D=Distal Diameter P=Proximal Diameter Lc=Length configurated Coil Selection The coil should fit inside the ampulla Diameter of distal cone D should be at the maximum 2 mm larger than the diameter D2 of the aortal orifice of the duct. Length of the configured coil (Lc) should not be longer than PDA length (L3). Pull through should be avoided Diameter of distal cone D should be at the minimum 3-4 mm larger than the diameter D1. (For short or window type PDA the diameter D1 should be 5 mm larger.) Selection of the Nit-Occlud Device (based on the measured PDA dimensions) D1 D2 Nit-Occlud dist x prox Coil Length Lc x4 5x4 6x5 6x5 7x6 9x6 4,5 5,0 D1 D2 Nit-Occlud dist x prox 3 7 7x x x 6 / 11 x 6* 4/ x 6 *depending on ductus type Coil Length Lc 4,5 5,0 5,0 / 6,0 6,0 These recommendations are valid for most ductus formations, however, specific anatomies might require different approaches. The more thrombogenic material inserted into the aortic ampulla, the more likely a complete occlusion will occur.

5 Clinical Data Case 1 Patient: female, 19 years 6 months old, 63 kg D1 = 4,0 mm, D2 = 10,0 mm, L = 7,0 mm Selected coil: 11 x 6 mm Prof. Dr. med. Sievert, CardioVasculäres Centrum, Frankfurt, Sankt Katharinen Dr. med. Lê, Universitätsklinik Eppendorf, Hamburg, Germany Case 2 Patient: female, 28 years old, 70,0 kg D1 = 2,9 mm, D2 = 8,0 mm, L = 5,4 mm Selected coil: 9 x 6 mm Prof. Dr. med. Sievert, CardioVasculäres Centrum, Frankfurt, Sankt Katharinen Case 3 Patient: female, 4 years old, 17 kg D1 = 3,0 mm, D2 = 10,0mm, L = 9 mm Selected coil: 9 x 6 mm Dr. med. Kozlik-Feldmann, Universitätsklinikum Großhadern, München, Germany Case 4 Patient: female, 5 years 9 months old, 18,5 kg D1 = 2,7 mm, D2 = 6,4 mm, L = 5,1 mm Selected coil: 7 x 6 mm Dr. med. Borges, Hospital de Clinicas Caracas, Venezuela Dr. med. Freudenthal, Klinikum der RWTH Aachen, Germany The flexible design of the Nit-Occlud coil allows optimal adaption to the ductus anatomy and therefore can be used for all ductus types..

6 Order Information Nit-Occlud coil system Pediatric & Adolescents Type REF Distal x Prox. Lc Implantation Length Coil Diameter mm catheter catheter x 4 mm Flex x 4 mm 4F 85 cm x 5 mm x 6 mm 4,5 Medium x 6 mm 5,0 5F 85 cm x 6 mm 6,0 Coil systems Flex and Medium are preloaded in a transportation sheath ready for transfer into introducer sheath (included). 10 mm 20 mm Occlu-Marker for angiography and measurement Pigtail Catheter for accurate aortographic measuremen of PDA size Exact DCI-calibration with 3 distal markers 10 and 20 mm apart REF Size Length Guide Wire Packing Unit F 50 cm F 75 cm F 90 cm Further sizes on request. Available without gold rings (standard DSA catheter) Multi-Snare Sets Positioning of implants and grasping of catheters and guidewires Variable loop diameter for precise sizing of the loop REF Snare Introducer Diameter Length Size Length mm (5-8) 125 cm 4 F 105 cm mm (10-15) 125 cm 4 F 105 cm mm (15-20) 125 cm 5 F 105 cm mm (20-30) 125 cm 6 F 105 cm mm (30-40) 125 cm 6 F 105 cm Multi-Snare single on request Multi-Snare Micro Sets Multi-Snare s dual-plane system increases grasping efficiency offering loop and lateral catching possibility REF Snare Introducer Diameter Length Size Length mm (2-3) 175 cm 3 F 150 cm mm (4-6) 175 cm 3 F 150 cm Multi-Snare single on request Certified by: ISO Manufacturer: pfm. Produkte für die Medizin AG Wankelstraße Köln, Germany Phone +49 (0) Fax +49 (0) customerservice@pfm-ag.com Products are subject to alterations Nit-Occlud : registered trademark in Germany PIE1006/ /1000/as