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The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is intended to dilate stenoses 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.

The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is an over-the-wire percutaneous transluminal angioplasty (PTA) catheter consisting of a proximal hub, dual lumen shaft, and a distal dilatation balloon. The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is compatible with guidewires with a maximum diameter of 0.035" and with 5, 6 or 7 FR introducer sheaths, depending on the diameter/length of the dilatation balloon. The catheter is provided with a hydrophilic coating and is available in useable catheter lengths of 40cm, 80cm and 120cm. The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter includes additional balloon lengths of 150 mm, 200 mm, 250 mm and 300 mm. The modified ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is manufactured from the same materials as the predicate ADMIRAL XTREME™ PTA Catheter and has the same Intended Use.

The SCUBA™ Biliary Stent System is indicated for use in the palliation of malignant neoplasms in the biliary tree

The SCUBA Biliary Stent System consists of a balloon-expandable MP35N (cobalt, nickel, chromium molybdenum alloy) stent mounted on a 5 F over-the-wire (OTW) balloon catheter. The stent is provided in nominal expanded diameters of 5 mm to 10 mm, and stent lengths of 18 to 75 mm. The SCUBA Biliary Stent System has an 80 cm usable length and is compatible with 6 or 7 F introducer sheaths, and guidewires up to 0.035" diameter.

The REEF HP 0.035" OTW PTA Balloon Dilatation Catheters are intended to dilate stenoses 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.

The Reef HP 0.035"OTW PTA Balloon Catheter is an over-the-wire percutaneous transluminal angioplasty (PTA) catheter consisting of a proximal hub, dual lumen shaft, and a distal non-compliant dilatation balloon. The REEF HP 0.035" OTW PTA Balloon Dilatation Catheter is compatible with guidewires with a maximum diameter of 0.035" and with 5, 6 or 7 FR introducer sheaths, depending on the diameter/length of the dilatation balloon. The catheter is provided in useable catheter lengths of 50 cm, 80cm and 120 cm.

The MO.MA® ULTRA Proximal Cerebral Protection Device is indicated as an embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures involving lesions of the internal carotid artery and or the carotid bifurcation. The reference diameter of the external carotid artery should be between 3-6 mm and the reference diameter of the common carotid artery should be between 5-13 mm.

The MO.MA® ULTRA Proximal Cerebral Protection Device consists of a multi-lumen shaft integrating two compliant occlusion balloons. The device is packaged with one hollow mandrel, one hemostatic valve with two-way stopcock and extension tubing, three 40 um filter baskets, one 30 cc syringe with male luer, one T-safety connector and two 1-way stopcocks. The MO.MA® ULTRA Proximal Cerebral Protection Device achieves cerebral protection by occluding the common carotid artery (CCA) and the external carotid artery (ECA) with two compliant balloons. Occluding the CCA and ECA produces blockage of antegrade and retrograde blood flow at the carotid bifurcation to prevent distal embolization of particulate debris and allow removal of particulate debris by blood aspiration.