![]() ![]() Each device was advanced through the track tester into a distal load cell and the maximum proximal and distal forces were measured and a percentage difference between the proximal and distal force was calculated. ![]() TEST METHOD for Pushability: Each device was tested using an MSI™ track tester water heater with water temperature of 37° ± 2☌. The catheter was then advanced through the lesion and maximum force (gf) and average force (gf) was measured. ![]() Each device was tracked through the track tester where the catheter tip was proximal to the lesion. A guidewire was used to cross the mock lesion. TEST METHOD for Crossability: Each device was tested using a lesion containment fixture and MSI™ track tester water heater with water temperature of 37° ± 2☌. Bench test results may not necessarily be indicative of clinical performance. 014 RX PTA Dilatation Catheter (Surmodics, Inc.) N = 5 Crosperio® RX (0.014) PTA Dilatation Catheter (Terumo Medical Corp.) N = 5 Ultraverse™ RX PTA Dilatation Catheter (Becton, Dickinson and Company) N = 5 Coyote™ Monorail Balloon Dilatation Catheter (Boston Scientific) N = 5 RapidCross™ PTA RX Balloon Dilatation Catheter (Medtronic, Inc.) N = 5. Average measurements from bench testing by Surmodics, Inc. 018 RX PTA Dilatation Catheters are contraindicated for use in the coronary arteries and the neurovasculature.Ī. 018 RX PTA Dilatation Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) dilation of peripheral vasculature stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Please refer to Instructions for Use for indications, contraindications, warnings, and precautions. Force was measured at a fixed percent compression of the shaft diameter.Ĭaution: Federal (US) law restricts this device to sale by or on the order of a physician. TEST METHOD for Radial Strength: Each test device was compressed between two flat plates. Devices were rotated clockwise one full rotation and maximum torque force on torque sensor was recorded. Devices were clamped into the torque test instrument on the distal end and rotated via the proximal hub. TEST METHOD for Torque: Each test device was placed into calibrated torque test instrument. This was continued until a kink was visually observed on the test device and the mandrel radius at which the kink occurred was recorded. If no kink occurred, the devices were made into a smaller loop and placed in the mandrel. Visual inspection of kink was administered. TEST METHOD for Kink-resistance: Each test device was made into a loop and placed into a kink resistance test fixture mandrel. R2P™ Destination Slender™ Guiding Sheath, 6 Fr (Terumo Medical Corp.) N = 5 Sublime™ Radial Access Guide Sheath, 5 Fr (Surmodics, Inc.) N = 5 Sublime™ Radial Access Guide Sheath, 6 Fr (Surmodics, Inc.) N = 5. The Guide Sheath is intended to introduce therapeutic or diagnostic devices into the vasculature, excluding the coronary and neurovasculature.Ī. ![]()
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