BTK Case Studies Joseph Cardenas, MD AZ Heart & Vascular, Yuma, AZ

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1 BTK Case Studies Joseph Cardenas, MD AZ Heart & Vascular, Yuma, AZ 1

2 Case 1 78 yr. old female Rutherford Class II/III lesion 1 block claudicant 2

3 Pre Treatment Post Treatment Anterior Tibial Artery Occlusion 1.75mm Peripheral RotaLink Plus Catheter, followed by 2.5x150mm PTA 3

4 Pre-Rota Post-Rota 1.75mm Rota Burr at Proximal cap 1.75mm Rota Burr through occlusion 2.5x150mm Post-PTA 160,000 RPM 1 min 48 sec total burr time 6 ATM for 1 min 4

5 Case 2 81 yr. old male Failed medical management 5

6 Pre Treatment Post Treatment Distal Popliteal Stenosis 2.00mm Peripheral RotaLink Plus Catheter, followed by 3x40mm PTA 6

7 Pre-Rota Post-Rota 2.00mm Rota Burr through Distal Popliteal Stand-Alone result 3x40mm Post-PTA 160,000 RPM 58 sec total burr time 8 ATM for 1 min 7

8 Case 3 64 yr. old male 2 block claudication 8

9 Pre Treatment Post Treatment Anterior Tibial Artery CTO 1.75mm Peripheral RotaLink Plus Catheter, followed by 2.5/3.0x220mm tapered PTA 9

10 10

11 Pre-Rota Post-Rota 1.75mm Rota Burr through ATA Stand-Alone result 2.5/3.0x220mm tapered Post- PTA 160,000 RPM 2 min 45 sec total burr time 6 ATM for 1 min 12

12 Case 4 72 yr. old male Failed medical management Single vessel run-off 13

13 Pre Treatment Post Treatment Ostial Anterior Tibial Artery Stenosis 1.75mm Peripheral RotaLink Plus Catheter, stand-alone 14

14 Pre-Rota Post-Rota 1.75mm Rota Burr through ATA Stand-Alone result 160,000 RPM 56 sec total burr time 15

15 Case 5 80 yr. old male Non-healing toe, hallux Antegrade stick 16

16 Pre Treatment Post Treatment Dorsalis Pedis Stenosis 1.50mm Peripheral RotaLink Plus Catheter, followed by 2x20mm PTA 17

17 Rotablator TM Rotational Atherectomy System Brief Summary Prior to use, please see the complete Directions for Use for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator s Instructions. CAUTION: Federal (U.S.) Law restricts this device to sale by or on the order of a physician. INTENDED USE/INDICATIONS FOR USE: The Rotablator Rotational Atherectomy System is intended for percutaneous use in the peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for endovascular procedures. CONTRAINDICATIONS: Occlusions through which a guidewire will not pass. Use in coronary arteries. Long ( 20 cm) total occlusions. Angiographic evidence of thrombus prior to treatment with the Rotablator Rotational Atherectomy System. Such patients may be treated with thrombolytics (e.g.,urokinase). When the thrombus has been resolved for two to four weeks, the lesion may be treated with the Rotablator Rotational Atherectomy System. Angiographic evidence of significant dissection at the treatment site. The patient may be treated conservatively for approximately four weeks to permit the dissection to heal before treating the lesion with the Rotablator Rotational Atherectomy System. RESTRICTIONS: Federal (USA) law restricts the use of this system to physicians who are credentialed in peripheral angioplasty and who have attended the Rotablator System Physician Training Program. PRECAUTIONS: Percutaneous rotational angioplasty with the Rotablator Rotational Atherectomy System should only be carried out at hospitals where emergency bypass surgery can be immediately performed in the event of a potentially injurious or life-threatening complication. Appropriate drug therapy including (but not limited to) anticoagulant and vasodilator therapy must be provided to the patient during all phases of patient care. When the Peripheral RotaWire Guidewires and/or Peripheral RotaLink Plus Catheters are in the body, they should only be manipulated while they are under fluoroscopic observation with radiographic equipment that provides high resolution images. Use only normal saline as the infusate. Never inject contrast agent, or any other substance that is not approved as part of the Rotablator Rotational Atherectomy System, into the infusion port or saline infusion bag as this may cause permanent damage to the Peripheral RotaLink Plus Catheter. ADVERSE EVENTS: Potential adverse reactions which may result from the use of this device include but are not limited to: Additional intervention, Allergic reaction, Amputation, Death, Embolism, Hematoma/Hemorrhage, Hemodynamic changes, Hemoglobinuria, Infection, Restenosis, Stroke, Slow, no flow, abrupt vessel closure, Surgery including arterial bypass, Thrombosis and vessel occlusion, Vessel trauma (dissection, perforation, psudoaneurysm, arteriovenous fistula). There may also be complications associated with distortion, kinks, and fracture of the guidewire and physical deterioration or malfunction of the device, which can lead to patient injury or death. WARNINGS: The risks of Rotational Atherectomy can be reduced if the device and associated accessories are used in the appropriate patient population by a physician who has had adequate training. The use of Rotablator for in-stent restenosis might lead to damage of stent components and/or Rotablator System, which may lead to patient injury. Rotablator, RotaLink, and RotaWire are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. All other trademarks are property of their respective owners. Results from case studies are not predictive of results in other cases. Results in other cases may vary. Case images and videos provided by Dr. Joseph Cardenas. 18

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