The Mounted CP Stent™ is comprised of a bare CP Stent® that is pre-mounted on a BIB® Catheter, eliminating the need to hand crimp the stent on a catheter.
- 12mm – 30mm balloon diameters
- 1.6cm – 6.0cm stent lengths
- 0.035" guidewire compatibility
- 110cm usable length
Indications for Use:
The Mounted CP Stent™ is indicated for use in the treatment of native and/or recurrent coarctation of the aorta involving a compliant aortic isthmus or first segment of the descending aorta where there is adequate size and patency of at least one femoral artery and balloon angioplasty is contraindicated or predicted to be ineffective.
Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. Contraindications: Clinical or biological signs of infection. Active endocarditis. Pregnancy. Contraindications: Patients too small to allow safe delivery of the stent without compromise to the systemic artery used for delivery. Unfavorable aortic anatomy that does not dilate with high pressure balloon angioplasty. Curved vasculature. Occlusion or obstruction of systemic artery precluding delivery or the stent. Known allergy to aspirin, other antiplatelet agents, or heparin. Warnings / Precautions: Radiofrequency heating during MRI scans on overlapped, 10 zig CP Stents has not been evaluated. Excessive force while crimping may weaken welds of the stent. Crimping the 8 zig stent on a balloon catheter smaller than 12mm, and the 10 zig on a balloon catheter smaller than 26mm, may cause damage to the stent. The stent is rigid and may make negotiation through vessels difficult. Warnings / Precautions: Coarctation of the aorta involving the aortic isthmus or first segment of the descending aorta should be confirmed by diagnostic imaging. The NuMED CP Stent has not been evaluated in patients weighing less than 20kg. As with any type of implant, infection secondary to contamination of the stent may lead to aortitis, or abscess. Over-stretching of the artery may result in rupture or aneurysm formation.