________________________________________________ DIAMONDBACK 360® Coronary Orbital Atherectomy System Including the DIAMONDBACK 360® Coronary Orbital Atherectomy Device, Saline Infusion Pump, and VIPERWIRE Advance® Coronary Guide Wire Instructions for use ____________________________________________________ Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
The following are trademarks of Cardiovascular Systems, Inc.
Explanation of symbols on package labels Refer to the package labels to see which symbols apply to specific products. Model number Caution - consult www.csi360.
Explanation of symbols on the Saline Infusion Pump Low saline red LED indicator Start button and green LED pump on indicator Pump status yellow LED indicator Prime button
Table of contents 1 System description…………………………………………………………………… 1 2 Indications for use…………………………………………………………………… 6 3 Contraindications……………………………………………………………………..6 4 Warnings…………………………………………………………………………….. 6 5 Precautions………………………………………………………………………….. 8 6 OAS component storage and handling……………………………………….. 7 Adverse events……………………………………………………………………… 10 8 Clinical study summary…………………………………………………………… 11 9 Equipment, set up, and test……………………………………………………….
Diamondback 360® Coronary Orbital Atherectomy System 1. System description The Cardiovascular Systems, Inc. (CSI) DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) is a catheter-based system designed for facilitating stent delivery in patients with coronary artery lesions.
Diamondback 360® Coronary Orbital Atherectomy System Figure 1. OAD P O A. B. C. D. E. F. G. H. I. J. K. L. M. N. O. P.
Diamondback 360® Coronary Orbital Atherectomy System Table 1. Crown sizes Model Number Crown Size (mm) Nose Length* (mm) Maximum Lumen (mm) OAD maximum catheter outer diameter (mm) Minimum guide catheter diameter DBEC-125 1.25 5 1.84 1.34 DBEC-150** 1.50 10 2.16 1.34 6 French with an internal diameter of at least 0.066 inches (1.68 mm) * Nose length is the length of the drive shaft from the crown to the distal tip of the shaft.
Diamondback 360® Coronary Orbital Atherectomy System 1.2 OAD package contents The OAD and accessories are supplied sterile and are for single-use only. Each package contains: 1.3 OAD Model DBEC-125 or DBEC-150 Saline tubing (connects the OAD to the OAS pump) OAS Pump The OAS pump provides the saline pumping mechanism and power to the OAD. The small, reusable, and portable OAS pump attaches to a standard five-wheel rolling intravenous (IV) pole (Figure 2).
Diamondback 360® Coronary Orbital Atherectomy System ____________________________________________________________ 1.4 OAS Pump package contents The OAS pump and accessories are supplied non-sterile. Each package contains: 1.
Diamondback 360® Coronary Orbital Atherectomy System Note: Please refer to the VIPERSLIDE Lubricant IFU prior to starting the atherectomy procedure. 2. Indications for use The DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions. 3.
Diamondback 360® Coronary Orbital Atherectomy System Do not re-sterilize or re-use the VIPERWIRE guide wire or the guide wire torquer. If the VIPERWIRE guide wire or torquer is re-sterilized or re-used, the guide wire may not function properly potentially leading to serious infection and patient harm and/or death. Never force the crown if any resistance is felt within the vessel as vessel perforation may occur.
Diamondback 360® Coronary Orbital Atherectomy System 5. The OAS was only evaluated in severely calcified lesions; therefore the scientific evidence to support use of the OAS to treat other types of lesions/patients is limited. Precautions Do not use the OAD if there is damage to the OAD package or if the OAD has reached its shelf life expiration date.
Diamondback 360® Coronary Orbital Atherectomy System 6. OAS component storage and handling 6.1 Storage Store all OAS components in a clean environment and away from humidity, magnets, and sources of electromagnetic interference (EMI). OAS performance may be affected if any OAS component is exposed to temperatures outside the range indicated on their individual package labels. 6.
Diamondback 360® Coronary Orbital Atherectomy System 7.
Diamondback 360® Coronary Orbital Atherectomy System 8. Clinical study summary The prospective, single arm, multi-center IDE study (ORBIT II) of the DIAMONDBACK 360 OAS was conducted to evaluate the safety and effectiveness of the OAS. Four hundred forty three (443) patients from 49 participating centers were enrolled in this study.
Diamondback 360® Coronary Orbital Atherectomy System Vessel calcification, as determined by the Investigator, is reported in Table 3. The overall mean length of calcium treated was 28.6 ± 0.8mm, ranging from 9.0 – 100 mm. Table 3. Vessel Calcification Characteristic Subjects N=440 Subjects with calcification determined by angiography only 405/440 (92.0%) Total length of calcium (including segmented) (mm) N 405 Mean ± SE 28.6 ± 0.8 Min – Max 9.0 - 100.
Diamondback 360® Coronary Orbital Atherectomy System Table 4. Primary Safety Endpoint (30-day MACE) Primary Safety Endpoint Freedom from MACE within 30 days postprocedure3 % [95% CI]1 Hypothesis2 89.6% [86.7%92.5%]4 HO: πs ≤ 83% HA: πs > 83% 1 Kaplan-Meier method used to obtain estimate of freedom from MACE. Peto’s method used to obtain the 95% confidence interval for the estimate. 2 πs is the probability of freedom from MACE within 30 days of the procedure of OAS device treatment.
Diamondback 360® Coronary Orbital Atherectomy System Table 6. Primary Effectiveness Endpoint Primary Effectiveness Endpoint % [95% CI]1 Hypothesis2 Procedural Success 88.9% [85.5%HO: πe ≤ 82% 91.6%]3 HA: πe > 82% 1 Clopper-Pearson Exact two-sided 95% confidence interval. 2 πe is the probability of the procedural success for OAS device measured by the success in facilitating stent delivery with < 50% residual stenosis and without inhospital MACE.
Diamondback 360® Coronary Orbital Atherectomy System Table 8 summarizes all serious adverse events observed through 30 days during the ORBIT II study. Table 8. Summary of SAEs through 30 Days Subjects N=443 Subjects Events n (%) N 60 (13.5%) 68 SAEs through 30 days Cardiovascular Disorders Acute MI, Q-wave 4 (0.9%) 4 Acute MI, non Q-wave 39 (8.8%) 39 Angina Pectoris 2 (0.5%) 2 Angina pectoris 2 (0.5%) 2 Atrial fibrillation 2 (0.5%) 2 Atrioventricular block, II degree 1 (0.
Diamondback 360® Coronary Orbital Atherectomy System Cardiac death Subjects N=443 Subjects Events n (%) N 1 (0.2%) 1 Non-cardiac death 1 (0.2%) 1 5 (1.1%) 5 91 (20.5%) 114 SAEs through 30 days Other Disorders Any Adverse Event Table 9 and Table 10, respectively, summarize the presence and types of dissections and perforations as assessed by the Angiographic Core Laboratory. Table 9.
Diamondback 360® Coronary Orbital Atherectomy System Table 11 summarizes the first observed occurrence of the dissection or perforation as assessed by the Angiographic Core Laboratory. Note: There is a possibility of dissection or perforation following OAS use. Table 11. Summary of Dissections and Perforations by Occurrence Prior to OAS Subjects N=52 8/52 (15.4%) Pre-OAS/post-balloon 0/52 (0.0%) Dissection First Identified Post-OAS 24/52 (46.2%) Post-OAS #1/post-balloon/pre-OAS #2 1/52 (1.
Diamondback 360® Coronary Orbital Atherectomy System Table 12. Summary of Subjects with Serious Adverse Events Related to Device/Procedure by Dissection Type 55/443 (12.4%) Number of Subjects with Dissections and SAEs Related to Device/Procedure 14/55 (25.5%) 52/443 (11.7%) 14/52 (26.9%) Type: A 9/52 (17.3%) 3/14 (21.4%) Type: B 22/52 (42.3%) 4/14 (28.6%) Type: C 8/52 (15.4%)2 1/14 (7.1%) Type: D 4/52 (7.7%) 3/14 (21.
Diamondback 360® Coronary Orbital Atherectomy System Table 13. Summary of Subjects with Serious Adverse Events Related to Device/Procedure by Perforation Type Number of Subjects Number of Subjects with Perforations and SAEs Related to Device/Procedure Perforation Rate (All Types) 9/443 (2.0%) 7/9 (77.8%) Coronary vessel perforation present on subjects treated with OAD 8/443 (1.8%) 6/8 (75.0%) Type: I 0/8 (0.0%) 0/6 (0.0%) Type: II 2/8 (25.0%) 2/6 (33.3%) Type: III 5/8 (62.5%) 3/6 (50.
Diamondback 360® Coronary Orbital Atherectomy System 9. Equipment, set up, and test 9.1. Equipment In addition to OAS components, equip the operating room with the following: Guide catheter - see Table 1 for guide catheter size recommendations Standard IV pole with five wheels and a 20 inch diameter base 1000 mL bag of sterile normal saline Fluoroscopic imaging equipment Standard 110 V hospital grade, electrical wall outlet Other equipment, as needed, for interventional procedures 9.2.
Diamondback 360® Coronary Orbital Atherectomy System c. not stretch or damage the spring distal tip while removing the VIPERWIRE guide wire from the packaging tube. Removing the VIPERWIRE guide wire – proximal end first: Grasp the exposed proximal end of the VIPERWIRE guide wire and gently pull the VIPERWIRE guide wire out of the packaging tube. Use care to not stretch or damage the spring distal tip while removing the VIPERWIRE guide wire from the packaging tube. 9.4.
Diamondback 360® Coronary Orbital Atherectomy System Figure 4. OAS pump control panel___________________________________ A. B. C. D.
Diamondback 360® Coronary Orbital Atherectomy System 9.5. Preparing the bag of saline and VIPERSLIDE Lubricant 1. 2. 3. Ensure that the OAS pump is powered off by pressing the Master Power switch on the back of the OAS pump to off and ensure that no LEDs are illuminated on the OAS pump panel (Figure 4). Prepare a full 1000 mL bag of normal saline solution with VIPERSLIDE Lubricant. Refer to the VIPERSLIDE Lubricant Instructions for Use for lubricant preparation instructions.
Diamondback 360® Coronary Orbital Atherectomy System 9.6. Connecting the OAD to the OAS pump Remove the sterile saline tubing from the OAD package and pass the saline bag spike end of the saline tubing out of the sterile field. Connect the other end of the saline tubing luer to the OAD luer. Additionally, pass the OAD power cord out of the sterile field. Perform the following: 1. 2. 3. 4. 5. 6. 7. 8. 9.
Diamondback 360® Coronary Orbital Atherectomy System 9.7. Testing the OAD 9.7.1. Testing OAD crown advancement Before inserting any portion of the OAD into the body, ensure that axial movement of the OAD crown advancer knob will produce smooth travel of the crown. Caution: Do not rotate the crown during this test. 1. 2. 9.7.2. Ensure that the crown advancer knob is in the unlocked position as this will allow free axial travel of the crown advancer knob.
Diamondback 360® Coronary Orbital Atherectomy System 4. 5. 6. 7. 8. Lock the VIPERWIRE guide wire in place by pressing down on the guide wire brake lever as the crown will not spin if the guide wire brake is unlocked. Verify that saline is still flowing freely out of the saline sheath tip. Verify that the saline tubing is properly connected to the saline bag, that the saline tubing routes correctly through the saline tubing guides, and that the saline tubing is properly connected to the OAD.
Diamondback 360® Coronary Orbital Atherectomy System 10. OAS directions for use 10.1. Performing the atherectomy procedure 1. 2. 3. 4. 5. Ensure that the OAD guide wire brake lever is open (in the up position). Advance the OAD drive shaft over the VIPERWIRE guide wire and through the hemostasis valve while keeping VIPERWIRE guide wire placement stationary. While using fluoroscopy, gently advance the OAD crown over the VIPERWIRE guide wire to a position approximately 1 cm proximal to the lesion.
Diamondback 360® Coronary Orbital Atherectomy System verify that the crown and the crown advancer knob are moving 1:1 with one another. Ensure that the OAD remains horizontal during the procedure to minimize saline leakage from the OAD handle. 10. Using a series of intermittent treatment intervals and rest periods, slide the crown advancer knob to move the crown back and forth across the lesion always returning to the proximal side of the lesion when the interval set is complete.
Diamondback 360® Coronary Orbital Atherectomy System saline level sensor as this will disable the Low Saline Information signal. 5. 6. 7. Remove the bag spike from the empty bag of saline and VIPERSLIDE Lubricant and spike the new bag of saline and VIPERSLIDE Lubricant. Power on the OAS pump by pressing the green Start button on the OAS pump control panel. Ensure that no air was introduced into the saline tubing.
Diamondback 360® Coronary Orbital Atherectomy System 10.1.2. Replacing the OAD If the OAD needs replacing, perform the following: 1. Stop the rotating crown and drive shaft by pressing and releasing the On/Off button on top of the crown advancer knob. 2. Disconnect the OAD power cord from the OAS pump. 3.
Diamondback 360® Coronary Orbital Atherectomy System 10.2. Completing the atherectomy procedure To complete the atherectomy procedure, perform the following: 1. 2. 3. While the crown is spinning, retract the crown and drive shaft proximal to the lesion. Stop the OAD crown and drive shaft rotation by pressing and releasing the On/Off button on top of the crown advancer knob. Carefully remove the OAD drive shaft and crown from the guide catheter and discard the OAD according to standard hospital protocol.
Diamondback 360® Coronary Orbital Atherectomy System 10.3.1. Cleaning the OAS Pump Clean the OAS pump immediately after each use by following the steps below: Caution: Ensure that the OAS pump is powered off at the Master Power switch on the back of the OAS pump and disconnect the OAS pump from wall power before cleaning the OAS pump. Caution: Do not immerse the OAS pump into fluids. Do not use solvents or abrasive cleaners to clean the OAS pump as these may damage the OAS pump and OAS pump components.
Diamondback 360® Coronary Orbital Atherectomy System 1. 2. 3. 4. 5. 6. Open a fresh, sterile wipe that is pre-saturated with 70% Isopropyl Alcohol (IPA) or prepare a sterile gauze/wipe by pouring or soaking it with 70% IPA. Wring any excess IPA from the gauze/wipe, ensuring that the gauze/wipe remains saturated, but not dripping, with IPA. Thoroughly wipe all surfaces on the front face of the OAS pump.
Diamondback 360® Coronary Orbital Atherectomy System 11. Specifications 11.1.
Diamondback 360® Coronary Orbital Atherectomy System 11.2. OAS pump specifications Parameter Volume Height Width Weight Electrical cable length: OAS pump to electrical outlet Value 1950 cm3 (119 in3) 20.3 cm (8.0 in) 25.4 cm (10.0 in) 4.0 kg (8.
Diamondback 360® Coronary Orbital Atherectomy System 12. OAS Pump Declaration of Conformity CSI declares that the coronary OAS is in conformity with the requirements of: IEC 60601-1. The OAS pump is compatible for use in a standard catheter laboratory environment. 13. EMC Declaration Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC).
Diamondback 360® Coronary Orbital Atherectomy System Appendices A. OAS troubleshooting If issues with the OAD cannot be resolved in each of the situations below, replace the OAD and continue with the procedure. Contact CSI Customer Service for returning OAS components. See the back of the instructions for use for CSI contact information. Issue number Issue 1 The crown stops rotating during the procedure 2 Blood is backing up into the OAD Solution 1. Immediately discontinue treatment.
Diamondback 360® Coronary Orbital Atherectomy System Issue number Issue 3 Crown rotational speeds are variable and will not stabilize 4 The OAD stops spinning and both crown rotation speed indicator LEDs on the OAD handle are illuminated 5 The crown is not moving one-to-one with the crown advancer knob Solution connected and blood continues to back into the OAD sheath, replace the OAD. 1. Immediately discontinue treatment. 2. Stop the OAD from spinning, but leave the OAS pump running. 3.
Diamondback 360® Coronary Orbital Atherectomy System Issue number Issue Solution until the crown moves with the knob. 6 7 The OAS pump will not power on and no LEDs are illuminated on the OAS pump control panel The OAS pump will not pump saline While spinning: 1. Immediately discontinue treatment. Stop the OAD from spinning, but leave the OAS pump running. 2. Verify the Tuohy valve is not overtightened. 3. Verify that the crown advancer knob moves smoothly. 4.
Diamondback 360® Coronary Orbital Atherectomy System Issue number Issue Solution saline tubing (i.e. bag spike) are properly connected and a sufficient amount of saline is in the saline bag such that the low saline level sensor is not active and the red LED on the OAS pump control panel is not illuminated. 3. Ensure that the OAS pump head is properly aligned with the OAS pump base. 4.
Diamondback 360® Coronary Orbital Atherectomy System Issue number 10 Issue Solution The low saline level sensor (red LED) is illuminated Note: The OAS pump will stop pumping saline and supplying power to the OAD 30 seconds after the low saline level sensor activates while the OAD is spinning. 1. 11 If there is less than 200 mL of saline left in the bag of saline and VIPERSLIDE Lubricant, replace the bag with a new 1000 mL bag of normal saline and VIPERSLIDE Lubricant solution. 2.
Diamondback 360® Coronary Orbital Atherectomy System Issue number Issue Solution by pressing the green Start button on the OAS pump control panel and verify that the green LED illuminates. 3. If the OAS pump does not restart after completing the abovementioned steps, press the Master Power switch to power off the OAS pump. Wait a few seconds and press the Master Power switch to power on the OAS pump. Verify that the OAS pump powers on.
Diamondback 360® Coronary Orbital Atherectomy System B. Maximum orbit and resulting lumen diameter The following table shows the maximum orbit and resulting lumen diameter for classic crown sizes, at incremental rotational speeds, for 20 passes (approximately 5 min of treatment time). Note: A pass is defined as once out and back across the lesion. Orbit data presented are based on a 6 cm pass distance at a travel rate of 1 cm per second. Minimum Reference Vessel Diameter* (mm) Crown Size (mm) 2.00 1.
Diamondback 360® Coronary Orbital Atherectomy System Orbit performance The following charts demonstrate typical orbit diameter vs. duration of operation (as measured in simulated calcified lesions.) These charts are for reference only. Actual orbit performance may vary. 1.25 mm Coronary Electric Classic Crown Orbit Results Low Speed (80 krpm) High Speed (120 krpm) 1.7 Orbit Diameter (mm) 1.65 1.6 1.55 1.5 1.45 1.4 1.35 1.3 1.
Manufacturer: Cardiovascular Systems, Inc. 651 Campus Drive St. Paul, MN 55112 USA 651-259-1600 1-877-CSI-0360 www.csi360.com © Cardiovascular Systems, Inc. 2013 90267-01.
