Driver stent ifu

Intended Use. The Medtronic Driver Coronary Stent Systems are indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions with reference vessel diameters of mm to mm and ≤30 mm in length using direct stenting or predilatation. The balloon dilatation catheter (balloon models mm– mm) is also indicated for post-delivery expansion of balloon-expandable stents. Note: Bench testing was conducted with the Sprinter™ Legend™ rapid exchange balloon dilatation catheter and marketed balloon-expandable stents. Consideration should be taken when this device is used. The Driver Coronary Stent has been shown to be MRI safe immediately following implantation at a field strength of up to Tesla, a maximum spatial gradient of .

stent, the Driver stent represents a benchmark for safety. The study met all endpoints, including a 48% reduction in target vessel failure (TVF—the combination of TVR and MACE) in the Endeavor group compared to the Driver group, and a 61% reduction in TLR at 9 months. At three years, the. INSTRUCTIONS FOR USE 1. Remove stent delivery system from package and backload device over a prepositioned wire guide, ensuring that the wire guide exits catheter at Zip port (Fig. A1, A2). 2. Unlock wire guide from Fusion Wire Guide Locking Device. 3. Introduce device in short increments into accessory channel of. SYNERGY™ MR OTW Coronary Stent System – eIFU CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

13 thg 4, invasive therapy based on re-opening narrowed arteries by stent insertion. (5) adequate radiopacity/magnetic resonance imaging (MRI). 10 thg 9, Compared to bare-metal stents (BMSs), drug-eluting stents (DESs) have been narrowed and in a worst case it is blocked (Driver ). 23 thg 7, Eight additional DESs have been included in this appraisal. Each DES has an instruction for use (IFU) document that includes the indications.