Categorisation committee for special medical materials announces the extension of the deadline for applications until 22.5.2014 to the following sub-groups:
XB5.6.2. Epicardial electrode for temporary pace stimulation
XB8. 1 Introduction sets for angiography and percutaneous radiological interventions
- short, extended, Reeled, hydrophilic, with soft toe, for aortic interventions (XL), for cross over access, carotic, drainage, for TIPS
XB8. 2 Drivers and microconductors for angiography and percutaneous radiological interventions
- standard 0.035, special (e.g. for aortic interventions) 0.035, hydrophilic 0.035, microconductors to the periphery 0.018, microconductors to the periphery 0.014, standard intracranial microconductors, microconductors to the intracranial 0.10, microconductors to the intracranial 0.008, special intracranial conductors, infusion conductors
XB8. 3 Diagnostic catheters and microcaters for angiography and percutaneous radiological interventions
- standard diagnostic catheters, hydrofiler catheters, periphery catheters with navigable tip, intervention aid and calibrated catheters 0.035, intervention aid 0.018, intervention aid 0.014, microcateters with navigable tip, microcateters for periphery embolization, standard microcateters intended for intracrania, DMSO compatible, microcateters with detachable end, guide catheter for peripheral interventions, guide catheter for extra and intracranial interventions, guide catheter with balloon for circulation andrest
XB8.4 Balloon catheters for percutaneous radiological interventions
- Standard (0.035) PTA catheters, low-profile (0.018) PTA catheters, low-profile (0.014) PTA catheters, spearhead PTA catheters (cutting PTA), scoring PTA catheters (scoring PTA), high-pressure PTA catheters, infusion PTA catheters, intracranial PTA catheters remodelling, intracranial PTA catheters dilating, PTA catheters with surface drug (DEB) 0.035, PTA catheters with surface drug (DEB) 0.018, PTA catheters with surface drug (DEB) 0.014, PTA catheters with surface drug (DEB) intended for intracrania, PTA catheters designed for cryoplasty, PTA catheters for non-vascular dilation, XL PTA catheters, other dilation devices (ortic equipment)
XB9.1.2 Drug-coated stents (DES) for percutaneous radiological interventions
- selfexpandable, balloonexpandable
XB9.1.3 Biodegradable stents for percutaneous radiological interventions
- Biodegradable (BDS)
XB9.1.4 Stents for percutaneous radiological neurointerventions
- intracranial remodeling, intracranial for bifurcation, intracranial for stenoses – balloonexpandable, intracranial for stenoses – self-expandable, intracranial thromboectomy
XB9.1.5 Uncoated stents (BMS) for percutaneous radiological interventions
- metal (BMS) selfexpandable for periphery, metal (BMS) balloonexpandable for periphery, low profile (0.018) selfexpandable, low profile (0.014) balloonexpandable, venous peripheral, venous intracranial, XL and aortic selfexpandable, XL and aortic balloonexpandable, aortic dissection, vascular
XB9.1.6 Uncoated stents (BMS) for implantation into coronary arteries
XB9.2 Stentgrafts for percutaneous radiological interventions
- Percutaneous peripherally self-expandable, percutaneous peripheral balloonexpandable, percutaneous to the chest aorta, percutaneous bifurcated to the abdominal aorta, expansion for bifurcated prostheses, low-profile peripheral, also suitable for intracranial, vascular, nonvascularly biodegradable, phenestrated (to measure), flowdiverters
XB11.1 Spiral for percutaneous radiological interventions
- koils, detachable koils, detachable rails with fibrillations, other koils, detachable micro-coils, botble micro-coils, coupling cable for detachment, detachment unit
XB13.1 Embolisation agents for percutaneous radiological interventions
- PVA particles, spherical particles, drug-releasing particles, liquid-embolic agent, alcohol, liquid-embolic agent, polymer, thrombin-based embolizing agent, sclerotizing agent, opacifying agent, detachable balloon, removable balloon for intracracking, occlusion, controlled detachment occlusion
XB13.2 Protection against embolisation in percutaneous radiological interventions
- Embolism protection device (EPD)
XB14.45 Revascularisation and thromboctomy devices for percutaneous radiological interventions
- aspiration thin wall catheters, thromboctomy catheters, thrombolytic infusion catheters, pulverization catheters, reolytic thromboectomy catheters and pharmacomechanical thrombolysis with accessories, mechanical thromboectomy catheters with accessories, atherectomic catheters with accessories, catheters for intracranial aspiration thromboectomy with accessories, catheter catheters for catheters, catheters for catheters, reentry devices
XB14.46 Intra-arterial invasive diagnostics for the extracoronary site
- IVUS sensor, FFR sensor, OCT sensor
XB14.47 Ablation catheters for percutaneous radiological interventions (except catheters in sub-group XB14.3.1) Renal denervation catheters)
- radio frequency ablation catheters standard, radio frequency ablation catheters special, laser ablation catheters, thermal ablation or microwave ablation catheters, cryoable catheters
XB14.48 Catheter access closing devices (CDs) - replace subgroups XB14.37, XB14.38 and XB14. 39
XB14.49 Auxiliary instrumentarium for percutaneous radiological interventions
- puncture needles, pressure syringe heads, pressure heads, micropuncture sets, bioptic sets, drainage sets, vertebroplastic sets, connecting ramps, manometric PTA syringes, high pressure coupling tubing, Y-containors, Y-connectors with valve, rotary adapter, drain bag nephrostomic, vacuum mammotomy set, egg recanalisation set, TIPS set, GI probe set, alien extractor lasies, complex lasages, other extraction equipment for periphery, intracranial circulation extraneous body extraction equipment, bone marrow puncture set, implantable port, central venous catheter, ACT set, angiographic set, endovascular intervention set, CO2 angiography set
The Categorisation Commission for Special Medical Materials will deal with applications submitted in 6/2014.