Rated Burst Pressure

14-27 atm to dilate resistant lesions

Radiopaque Marker Bands

Facilitate precise balloon positioning

Semi-compliant Nylon Balloon

Promotes vessel conformability and resists vessel straightening

The high pressure Dynamis AV™ balloon is designed to dilate resistant lesions while conforming to the vessel, as demonstrated in the case studies below.

INDICATIONS

The UHP PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries, and for the treatment of obstructive.

CONTRAINDICATIONS

None known for PTA procedure. This0.035” PTA Balloon Dilatation Catheteris contraindicated for use in the coronary arteries, the neurovasculature and for the delivery of stents.

WARNINGS

• This device is intended for single use only; do not reuse. Do not re-sterilize, as this can compromise device performance, and increases the risk of cross contamina-tion due to inappropriate reprocessing.

• approximate the diameter of the vessel just proximal and distal to the stenosis in Percutaneous Transluminal Angioplasty (PTA).

• When the catheter is exposed to the vascular system, it should be manipulated.

• If resistance is met during manipulation, determine the cause of the resistance before proceeding.

• Balloon pressure should not exceed the rated burst pressure (RBP). Refer to the product prevent over pressurization, use a pressure monitoring device.

• Do not use with Lipiodol contrast media, or other such contrast media which incorporate the components of this agent.

• Do not use, or attempt to straighten, a catheter if the shaft has become bent or kinked; this may result in the shaft breaking. Instead prepare a new catheter.

Potential adverse events include but are not limited to: • Thrombus • Vessel dissection, perforation, rupture or spasm • Death • Abrupt closure • Acute myocardial infarction • Acute or subacute thrombosis • Additional intervention required (major, moderate) • Allergic reaction (device, contrast medium and medications) • Amputation • Angina • Air embolization • Aneurysm • • • Coma • Embolization, which includes thromboembo-lization (arterial, pulmonary) • Hematoma/ Pseudoaneurysm at puncture site • Hemorrhage, including bleeding at puncture site • Hypotension/Hypertension • • Intimal tear • Ischemia, including tissue ischemia, steal syndrome and necrosis • Neurological events, including peripheral nerve injury and neuropathies • Occlusion • Organ failure (single, multiple) • Paralysis • Pyrogenic reaction • Renal failure • Seizures • Sepsis/infection • Shock • Stroke • Transient ischemic attack • Weakness