Atherectomy +
Thrombectomy For Mixed Morphology PAD
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Rotarex™ Rotational Excisional Atherectomy System Safety and Risk Information: The Straub Endovascular System is herein referred to as the BD Rotarex™ a Rotarex™
single use catheter, the Straub Endovascular System is intended for use as an atherectomy device and to break up and remove thrombus from upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotid, pulmonary, iliac or renal vasculature. Contraindications: Use of the Rotarex™
Rotational Excisional Atherectomy System Indication For Use: When operated with
the target lesion · Where the Straub provided guidewire is in a subintimal position of any length · Where the Straub provided guidewire has become threaded or entangled in the wire mesh of a stent, stent graft or the lining of a stent graft · Where the target lesion is located in a region of marked vessel tortuosity (has a radius of curvature ≤2 cm) or is heavily calcifi ed · Where pre-existing damage is present in the vessel wall at or near the target lesion from prior surgery, aneurysms or other disease · During MRI procedures or where electrical current may be passed to an undesired location via the catheter, e.g., during electrocautery, electrosurgery or defi brillation. The Rotarex™
these therapies are administered, even in an emergency situation· Where the recommended separation distances from Radio Frequency and Electro-Magnetic Interference (EMI) sources cannot be maintained (Reference the manual for the Drive System) · Where any component of the Straub Rotarex™
Endovascular System has sustained damage, including any breech of the sterile barrier. Please consult package insert for more detailed safety information and instructions for use. catheter and guidewire must be entirely removed before
vasculature · In instances of persistent vasospasm · In patients not suitable for atherectomy/ thrombectomy · In patients with known or suspected allergies to any component of the Straub Endovascular System · In patients with hemodynamic instability, shock or severe coagulatory disorders · In patients where it is impossible to achieve suffi cient anticoagulation and platelet aggregation inhibition · In areas of known or suspected infection, especially at the puncture site or target vessel segment · In vessels which are oversized or undersized for the particular Rotarex™
catheter used · In stents, stent grafts or bypass grafts · Without the use of a Straub provided guidewire · When the Straub provided guidewire cannot completely cross family of catheters is contraindicated in the following situations and locations: · In the cardiopulmonary, coronary, cerebral, iliac and renal vasculature · In the venous
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