Orbital Atherectomy Debulks and Fractures Calcium with One Device
Diamondback 360™ Precision Coronary Orbital Atherectomy System (OAS) safely debulks superficial calcium and fractures deeper calcium to optimize stent delivery, expansion and apposition.1-5
Calcium fracture with orbital atherectomy has been observed in several single center studies and case studies in various calcium morphologies and lesion types.2,3,6-8 Calcium modification by Diamondback 360™ Precision Coronary Orbital Atherectomy System (OAS) facilitates post-stent calcium fracture even in regions of thick calcium as assessed by Optical Coherence Tomography (OCT).2
Pre-OA
Post-OA
Post-Stent
Example: Pre-OA, post-OA, and post-stent. Post-OA shows characteristic calcium reduction at the white arrows, followed by calcium fracturing observed post-stent at the white arrows.
Images courtesy of Evan Shlofmitz, DO
Effect of Orbital Atherectomy in Calcified Coronary Artery Lesions as Assessed by Optical Coherence Tomography2
Calcium modification using OA facilitates post-stent calcium fracture even in areas with thick calcification, leading to improved stent expansion.
58 patients with calcific lesions treated with OA. OCT performed pre-procedure, post-OA and post-stent. Fracture defined as complete discontinuity of calcium.
- 60% of lesions exhibit post-stent calcium fracture.
- Fracture most prevalent (90%) in upper tertile lesions (with greatest calcium arc and thickness).
- The presence of calcium fracture was an independent predictor of optimal stent expansion.
Authors' conclusions: Modification of calcium using OA promotes post-stent calcium fracture, including in areas with thick calcification as assessed via OCT. Increased calcium modification is associated with more extensive fracturing, which subsequently facilitates stent expansion.
Upper panels show the distribution of maximum fractured calcium thickness with OA calcium modification. The lower panel shows the distribution of maximum fractured calcium thickness without OA calcium modification. Calcium fracture modified by OA was observed in thicker calcium than those without modification by OA.
Initial Experience with Orbital Atherectomy in a Tertiary Centre in the Netherlands6
Experience with OA in heavily calcified coronary lesions showed effective debulking and plaque modification, accompanied by high procedural success and clinical safety.
29 patients with 39 severely calcified lesions treated with OA. OCT and/or IVUS performed pre-OA, post-OA, and post-stenting. (Fracture not defined.)
- Superficial sanding of calcium in 90% of lesions.
- Fracturing of deeper medial calcium in 63% of lesions.
- OA appeared to be particularly effective in the ablation of calcified nodules, with 94% of nodules being removed.
Authors' conclusions: OA modifies coronary calcium by sanding and fracturing both superficial and deeper medial calcium. Mechanistically, combining rotational atherectomy (RA) with intravascular lithotripsy (IVL) may offer more complementary benefits than pairing OA with IVL. This is because RA does not effectively target deeper medial calcium, which IVL can subsequently address. In contrast, OA’s orbital motion allows it to reach and modify deeper calcium, potentially reducing the need for IVL. Additionally, OA demonstrated complete elimination of calcified nodules—possibly due to reduced guidewire bias compared to RA.
Example of superficial sanding, medial calcium fracture and fractured calcified nodule. Asterisks indicate the different modification patterns of OA.
Optical Coherence Tomography Assessment of the Mechanistic Effects of Rotational and Orbital Atherectomy in Severely Calcified Coronary Lesions3
Despite similar dissection rates, OA achieves deeper tissue modifications than RA, potentially leading to improved stent apposition.
20 consecutive patients treated with OA (10) or RA (10). OCT performed post-atherectomy and post-stent. Calcium dissection (fracture) was defined as a disruption of the arterial lumen surface seen in at least 2 consecutive cross-section images.
Authors' conclusions: While the rate of dissections was similar between RA and OA procedures, OA led to deeper tissue modifications visible by OCT imaging. This may help explain a better stent apposition after OA relative to RA. Further research is needed to understand the implications for long-term outcomes.
Type I
Type II
Type III
OCT findings after atherectomy in calcified de novo lesions. Representative OCT images and measurements for different types of post atherectomy tissue modification (TM):
- Type I-nodules, or superficial intimal flaps with smooth luminal border (A, B).
- Type II-post RA fissures (C) and post OA gutters (D), deep intimal cuts with irregular intima-lumen interface (asterisks).
- Type III-post RA craters (E) and post OA lacunae (F), deep intimal-medial dissections with noncylindrical lumen (asterisks).
White lines and numbers show nodules length in (A, B) and the depth of the fissures (C), gutters (D), craters (E), and lacunae (F).
Note: The study by Kini et al. included cases with moderate to severe coronary calcium. The Diamondback 360™ Coronary Orbital Atherectomy System is not indicated for moderate calcium. The findings from this article should be interpreted in the context of the other studies presented on this page.
Case Study Examples of Calcium Fracture with Orbital Atherectomy
Orbital Atherectomy for Calcified Nodule: Optical Coherence Tomography Assessment7
OCT revealed an arc of calcium >180°, thickness of 0.6 mm, and length > 5 mm with a calcified nodule with a minimum lumen area of 3.49 mm2 (C). OA was selected to prepare the lesion. After 5 runs at low speed (80 000 rpm), a new OCT was performed that confirmed the fracture of the calcified nodule achieving a minimum lumen area of 7.5 mm2 (D). Both the post-stenting final coronary angiogram (B) and the OCT pullbacks confirmed the homogeneous expansion.
Observational Study Evaluating the Efficacy of Orbital Atherectomy in Treating Calcified Coronary Lesions8
20 patients with severely calcified lesions (≥180°). In all patients, OCT confirmed fracture of both superficial and deep calcium (defined as fissures, craters, and in some typical smooth concave ablation).
References
- Shlofmitz E, Martinsen BJ, Lee M, et al. Orbital Atherectomy for the Treatment of Severely Calcified Lesions: Evidence, Technique, and Best Practices. Expert Rev Med Devices. 2017;14(11):867-879.
- Yamamoto MH, Maehara A, Kim SS, et al. Effect of Orbital Atherectomy in Calcified Coronary Artery Lesions as Assessed by Optical Coherence Tomography. Catheter Cardiovasc Interv. 2019;93(7):1211-1218.
- Kini AS, Vengrenyuk Y, Pena J, et al. Optical Coherence Tomography Assessment of the Mechanistic Effects of Rotational and Orbital Atherectomy in Severely Calcified Coronary Lesions. Catheter Cardiovasc Interv. 2015;86(6):1024-1032.
- Shlofmitz E, Jeremias A, Shlofmitz R, Ali ZA. Lesion Preparation with Orbital Atherectomy. Interv Cardiol. 2019;14(3):169-173.
- Yamamoto MH, Maehara A, Karimi Galougahi K, et al. Mechanisms of Orbital Versus Rotational Atherectomy Plaque Modification in Severely Calcified Lesions Assessed by Optical Coherence Tomography. JACC Cardiovasc Interv. 2017;10(24):2584-2586.
- den Dekker WK, Siskos AA, Wilschut JM, et al. Initial Experience with Orbital Atherectomy in a Tertiary Centre in the Netherlands. Neth Heart J. 2023:31(5):196–201.
- Abellas-Sequeiros M, Sanchez-Recalde A, Sanz A, et al. Orbital Atherectomy for Calcified Nodule: Optical Coherence Tomography Assessment. REC Interv Cardiol. 2022;4:163-164.
- Ayat Y, Kessler K, Avula S. Observational Study Evaluating the Efficacy of Orbital Atherectomy in Treating Calcified Coronary Lesions. Presented at EuroPCR 2021.
MAT-2643368 v1.0
Important Safety Information
Diamondback 360™ and Diamondback 360 Precision™ Coronary Orbital Atherectomy System
Including the Orbital Atherectomy Device (OAD) with GlideAssist™, Saline Pump, ViperWire Advance™ Coronary Guide Wire, and ViperWire Advance™ with Flex Tip Coronary Guide Wire
INDICATIONS
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.
CONTRAINDICATIONS
Use of the OAS is contraindicated for use in the following situations:
- The ViperWire™ guide wire cannot pass across the coronary lesion.
- The target lesion is within a bypass graft or stent.
- The patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy.
- The patient has angiographic evidence of thrombus.
- The patient has only one open vessel.
- The patient has angiographic evidence of significant dissection at the treatment site.
- Women who are pregnant or children.
WARNINGS
- Do not use the OAS if the physician does not have experience in coronary angioplasty at their institution.
- Do not use the OAS if the physician does not have training on using the OAS. Contact a CSI representative for information on training.
- Do not use other commercially-available guide wires with the OAD. Only use the Model GWC-12325LG-FLP ViperWire Advance™ Coronary Guide Wire or GWC- 12325LG-FT ViperWire Advance™ Coronary Guide Wire with Flex Tip with the coronary OAD. The ViperWire™ guide wire is designed for use with all coronary OAD crown and shaft configurations.
- Never operate the OAD without normal saline and ViperSlide™ Lubricant. Continually flowing saline and ViperSlide Lubricant is required for cooling and lubricating the OAD during use in order to avoid overheating and permanent damage to the device and possible injury to the patient.
- Do not use the OAD or the ViperWire™ guide wire if their sterile package barriers are compromised or damaged.
- Do not use device during spasm of the vessel.
- Do not re-sterilize or re-use the OAD. If the OAD is re-sterilized or re-used, the OAD may not function properly potentially leading to serious infection and patient harm and/or death.
- 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 use force to advance the spinning crown as vessel perforation may occur. If any resistance to crown travel is felt, reposition the crown away from the lesion, immediately stop treatment, and use fluoroscopy to assess the vessel for any complications. If it is confirmed there are no complications, reposition the device and advance and retract at a targeted rate of 1 to 3 mm per second.
- Use fluoroscopy to monitor and maintain spacing between the driveshaft and guide wire spring tip throughout the procedure. Always keep more than 5mm of spacing between the distal end of the OAD driveshaft and the proximal end of the guide wire spring tip. If the distance between the driveshaft tip and the ViperWire™ guide wire spring tip is insufficient, the driveshaft tip may contact the guide wire spring tip and result in dislodging the guide wire spring tip.
- Immediately stop using any OAS component should mechanical failure of any component occur before or during the atherectomy procedure. Using damaged components may result in OAS malfunction or patient injury.
- Immediately stop use of the OAD if the device stalls. Review for complications if a stall condition occurs. Do not change to high speed if device stalls on low speed.
- Note: If a stall occurs, the On/Off button is inactive for five seconds. If the On/Off button is pressed during this five second lockout period, the lockout period will begin again.
- Initial treatment for each lesion must start at low speed.
- Do not continue treatment if the wire or the device becomes subintimal.
- Do not operate the OAD if there is a bend, kink, or tight loop in the ViperWire™ guide wire. A bend, kink, or tight loop in the ViperWire™ guide wire may cause damage to and malfunctioning of the device during use.
- Performing treatment in excessively tortuous or angulated vessels or bifurcations may result in vessel damage or device failure requiring retrieval.
- Always keep the crown advancing or retracting, while it is orbiting, by continually moving the crown advancer knob to ensure corresponding (1:1) movement between the crown advancer knob and the orbiting crown.
- Do not start or stop orbiting of the crown when tight in a lesion.
- Once the OAD has reached full speed (as indicated by a stable pitch) continue to maintain a targeted travel rate of 1 to 3 mm per second, and do not exceed 10 mm per second. If the orbiting crown remains in one location it may lead to vessel damage.
- Maximum total treatment time should not exceed 5 minutes. If maximum total treatment time exceeds 5 minutes, the OAD shaft, crown, and ViperWire™ guide wire may begin to exhibit signs of wear and result in a device malfunction and possible injury to patient. A team member should track run time during use to verify total run time is not exceeded.
- Do not advance or retract the orbiting crown by advancing the OAD sheath or handle. Buckling of the ViperWire™ guide wire may occur resulting in vessel perforation or vascular trauma. Always advance the orbiting crown by using the crown advancer knob.
- Do not inject contrast solution into the OAD injection port. Device failure or patient harm may occur.
- Do not attempt aspiration through the OAD or saline line while placed within the body. If saline is pulled out through the OAD or saline line, air may enter the system.
- If air is noticed in the system while the OAD is within the body, discontinue treatment by pressing the OAS Pump power button and carefully remove the OAD driveshaft and crown from the introducer sheath/guide catheter.
- Do not allow body parts or clothing to come into contact with spinning components as the OAD orbits at very high speeds. Physical injury to the user or entanglement of clothing with the crown may occur.
- 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.
- Do not spin the crown in GlideAssist™, with the guide wire brake lever in the unlocked position, without first securing the guide wire by holding it with fingers or by using the guide wire torquer. If using the guide wire torquer, ensure that it is securely fastened to the guide wire before starting to spin the crown. Failure to secure the guide wire when the brake is unlocked could allow the guide wire to spin while in GlideAssist™ mode which may result in patient harm.
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.
- If using an adjustable hemostasis valve with the guide catheter, close the hemostasis valve to minimize blood loss from around the guide catheter while still allowing the OAD sheath to slide through the hemostasis valve. Avoid excessive tightening of the hemostasis valve to prevent damaging the OAD catheter sheath. When inserting or removing the OAD crown or drive shaft through the hemostasis valve, use care not to deform the drive shaft.
- If crown and crown advancer knob movements are not moving correspondingly with one another (1:1 movement), retract and re-advance the crown into the lesion using a travel rate between 1 to 3 mm per second. Repeat retracting and advancing the crown into the lesion until crown to crown advancer knob movement correspondence is observed. If the knob and the crown are not moving together, the crown may be driven into the lesion with too much force and may result in the crown springing forward on exiting the lesion.
- Follow standard institution atherectomy policies and procedures, including those related to anticoagulation, channel blockers, and vasodilator therapy.
- Ensure fluoroscopy provides adequate visualization of the OAS system. Always use fluoroscopy to monitor the guide wire spring tip and driveshaft positions at all times throughout the procedure. If wire movement occurs, it is suggested to reposition the guide wire before advancing the device or continuing treatment.
- Applies to Diamondback 360™ Precision Coronary OAS only: Verify that contrast media injections are not above 400 psi and are not occurring during spinning of the crown.
- Applies to Diamondback 360™ Precision Coronary OAS only: If using a guide catheter smaller than 0.071 inches (1.80 mm), contrast media flow may be reduced.
- A temporary pacing lead may be necessary when treating lesions in the right coronary and circumflex arteries due to the possible occurrence of electrophysiological alternations.
- The risk of the occurrence of a dissection or perforation is increased in severely calcified lesions undergoing percutaneous treatment; therefore, on-site surgical back- up should be included as a clinical consideration. If onsite surgical back-up is not provided, then an agreement with an alternative hospital should be considered, in advance of the procedure, where the patient could be transferred in an emergency situation.
- Do not kink or crush the saline tubing as this will reduce the flow of saline and ViperSlide™ Lubricant to the OAD.
- Continually monitor and check the saline tubing and connections for leaks during the procedure.
- Do not spin the crown while advancing or retracting the crown within a guide catheter or tuohy. Damage to the guide catheter, tuohy, and/or OAD may occur.
- Ensure the OAD strain relief remains straight during atherectomy treatment. If the OAD strain relief does not remain straight, the shaft/sheath can kink.
- Do not sterilize the OAS pump. Sterilizing will damage the OAS pump. The OAS pump is intended to be used and maintained outside of the sterile field. Reference the Instructions for Use on cleaning and disinfecting the OAS pump.
- Do not allow fluid to leak onto electrical connections of the OAS pump.
- Do not spin the crown without a seated and supportive guide catheter
- When treating from a larger lumen to a smaller lumen, make sure the guide catheter is coaxial and that the tip of the OAD has entered the coronary artery to control the initial orbit before engaging the crown; engage the OAD tip into the tight stenosis until low speed has reached its treatment potential prior to initiating treatment with high speed.
- To relieve compression in the driveshaft, lock the crown advancer knob at 1cm from the full back position, advance device over wire to a position proximal from the lesion, deploy the guide wire brake, then unlock the crown advancer knob and move it fully proximal. If the OAD is started with existing compression in the driveshaft it may result in the crown springing forward.
- Do not flip contents of tray into sterile field as damage may occur. Components within tray must be carefully removed and placed into sterile field to avoid damage.
- Ejection fractions less than 25% have not been studied, use with low ejection fractions may require additional precautions due to compromised heart function.
POTENTIAL ADVERSE EVENTS
Potential adverse events that may occur and/or require intervention include, but are not limited to:
- Allergic reaction to medication/media/device components. Aneurysm. Angina (ischemic chest pain). Arrhythmias. Arteriovenous fistula. Bleeding. Bruising/hematoma. Cardiac/cardiopulmonary arrest. Cardiac/pericardial tamponade. Cerebrovascular accident (CVA). Death. Embolization, distal (air, tissue, thrombus, device). Emergent coronary artery bypass graft surgery (CABG). Failure to deliver the system to the intended locations. Fever. Heart failure/dysfunction. Hemorrhage, requiring transfusion. Hypotension/hypertension. Infection. Myocardial infarction. Pain. Pericardial effusion. Pseudoaneurysm. Restenosis of treated segment leading to revascularization. Renal insufficiency/failure. Shock (cardiogenic, hypovolemic). Slow flow or no reflow phenomenon. Stroke. Thrombus. Vessel closure, abrupt. Vessel injury, requiring surgical repair. Vessel dissection, perforation, rupture, or spasm. Vessel occlusion.
Diamondback 360™ and Diamondback 360 Precision™ Coronary Orbital Atherectomy System are manufactured and distributed by Cardiovascular Systems, Inc. (CSI). CSI is a subsidiary of the Abbott Group of Companies.
MAT-2303956 v1.0
OPTIS™ and OPTIS™ Next Imaging Systems and Software
INDICATIONS
Applies to OPTIS™ Imaging Systems and Software
The OPTIS™ Software and AptiVue™ E Series Software are intended to be used only with compatible OPTIS™ Imaging Systems.
The OPTIS™ Imaging Systems with a compatible Dragonfly™ Imaging Catheter are intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The compatible Dragonfly™ Imaging Catheters are intended for use in vessels 2.0 to 3.5 mm in diameter. The compatible Dragonfly™ Imaging Catheters are not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
The OPTIS™ Imaging Systems are intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.
Applies to OPTIS™ Next Imaging Systems and Software
The Ultreon™ 1.0 Software and Ultreon™ 2.0 Software are intended to be used only with compatible OPTIS™ Next Imaging Systems.
The OPTIS™ Next Imaging System with a compatible Dragonfly™ OPTIS™ Imaging Catheter or Dragonfly OpStar™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly™ OPTIS™ Imaging Catheter or Dragonfly OpStar™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ OPTIS™ Imaging Catheter or Dragonfly OpStar™ Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
The OPTIS™ Next Imaging Systems are intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if therapeutic intervention is indicated.
Applies to both OPTIS™ and OPTIS™ Next Imaging Systems and Software
The Dragonfly™ OPTIS™ or Dragonfly™ OpStar™ Imaging Catheters are intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ OPTIS™ or Dragonfly™ OpStar™ Imaging Catheters are not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
The OPTIS™ and OPTIS™ Next Imaging Systems are intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if therapeutic intervention is indicated.
CONTRAINDICATIONS
The OPTIS™ and OPTIS™ Next Integrated Systems and Mobile Systems with the usage of the OPTIS™ Software, AptiVue™ E Series Software, Ultreon™ 1.0 Software, and Ultreon™ 2.0 Software are contraindicated where introduction of any catheter would constitute a threat to patient safety. Contraindications include:
- Bacteremia or sepsis
- Major coagulation system abnormalities
- Patients diagnosed with coronary artery spasm
- Patients disqualified for coronary artery bypass graft (CABG) surgery
- Patients disqualified for percutaneous transluminal coronary angioplasty (PTCA)
- Severe hemodynamic instability or shock
- Total occlusion
- Large thrombus
- Acute renal failure
- Inability to tolerate systemic anticoagulation is a contraindication to use of OCT for coronary imaging.
- The system has no patient alarm functions. Do not use for cardiac monitoring.
COMPLICATIONS
The following complications may occur as a consequence of intravascular imaging and catheterization procedure:
- Abnormal heart rhythm or arrhythmias
- Acute myocardial infarction
- Allergic reaction to the contrast media or drug administered for the procedure
- Arterial dissection, injury, or perforation
- Bleeding
- Catheter access site reactions: inflammation or granuloma
- Coronary artery spasm
- Death
- Embolism
- Hypotension
- Infection
- Myocardial ischemia
- Renal insufficiency or failure from contrast media use
- Repeat revascularization
- Thrombus formation, abrupt closure, or total occlusion
- Tissue necrosis
- Unstable angina
WARNINGS
- Prior to use, please review the Instructions for Use supplied with the OPTIS™ imaging system, Dragonfly™ Imaging Catheter, Wi-Box™ AO Transmitter and the PressureWire™ guidewire for more information.
- The Dragonfly™ Imaging Catheter is sterilized by ethylene oxide and is intended for one time use only. Non-pyrogenic. Do not use if the package is opened or damaged. Do not reuse or re-sterilize. Any attempt to reuse or re-sterilize may compromise the structural integrity of this device. Adverse effects of using a non-sterile or re-sterilized catheter may include, but are not limited to: local and / or systemic infection, mechanical damage, inaccurate results.
- Appropriate anticoagulant and vasodilator therapy must be used during the procedure as needed.
- Ensure that no air is introduced into the system during the Dragonfly™ Imaging Catheters insertion.
- Observe all advancement and movement of the Dragonfly™ Imaging Catheters under fluoroscopy. Always advance and withdraw the catheter slowly. Failure to observe device movement fluoroscopically may result in vessel injury or device damage. To ensure proper placement, do not move the guide wire after a Dragonfly™ Imaging Catheter is in place.
- If resistance is encountered during advancement or withdrawal of the Dragonfly™ Imaging Catheter, stop manipulation and evaluate under fluoroscopy. If the cause of resistance cannot be determined or mitigated, carefully remove the Dragonfly™ Imaging Catheters and guidewire together as a unit from the patient.
- Leave the guide wire engaged with a Dragonfly™ Imaging Catheter at all times during use. Do not withdraw or advance the guide wire prior to withdrawing the Dragonfly™ Imaging Catheters.
- The Dragonfly™ Imaging Catheters should never be forced into lumens that are narrower than the Dragonfly™ Imaging Catheters body or forced through a tight or heavily calcified lesion.
- The Dragonfly™ Imaging Catheters should not be advanced through abnormally tortuous anatomy.
- When advancing or retracting a Dragonfly™ Imaging Catheter with a monorail tip through a stented vessel, the Dragonfly™ Imaging Catheters may engage the stent between the junction of the Dragonfly™ Imaging Catheters and guide wire, resulting in entrapment of catheter / guide wire, catheter tip separation, stent dislocation, and / or vascular injury.
- Refer to the contrast media Instructions for Use for general warnings and precautions relating to use of contrast media.
- Before creating an OCT recording, review “Performing an OCT Procedure” for additional warnings and cautions in the IFU.
PRECAUTIONS
- Safety and effectiveness have been established for the following patient population: adult patients undergoing non-emergent percutaneous coronary interventions in lesions with reference vessel diameters between 2.0 to 3.5 mm, which are not located in the left main coronary artery or in a target vessel which has undergone previous bypass procedures.
- Follow all instructions, warnings, and cautions provided in “Patient Safety” in the IFU.
- All operators must be knowledgeable in performing OCT and physiological procedures prior to using the OPTIS™ and OPTIS™ Next Integrated Systems and Mobile Systems with the usage of the OPTIS™ Software, AptiVue™ E Series Software, Ultreon™ 1.0 Software, and Ultreon™ 2.0 Software.
- When using saline, heparinized saline is recommended.
- Monitor the OCT image for indications of the Dragonfly™ Imaging Catheters optical failure. If optical failure is suspected, remove the Dragonfly™ Imaging Catheter from the patient, press “Unload” on the drive motor and optical controller (DOC), detach the catheter, and replace it with a new one.
- If the pullback triggers before contrast is injected, repeat the pullback.
- For optimal imaging, only use 100% contrast media.
- Use the minimum flush rate and volume required to image the desired anatomy.
- To obtain accurate measurements, be sure the selection for the Flush Medium is the same as the medium in which you are imaging.
- The Dragonfly™ Imaging Catheters must be purged prior to connection to the DOC to prevent damage to the imaging core.
- Do not insert or remove a Dragonfly™ Imaging Catheter while the DOC is scanning. Do not attempt to disconnect the catheter from the DOC while the “lock” LED is blinking as it could damage the catheter or the DOC. Refer to “Removing the Dragonfly™ Imaging Catheter” in the IFU.
- Never attempt to attach or detach a catheter to the DOC while the "lock" LED is lit.
- Take care in handling the Dragonfly™ Imaging Catheters to prevent breaking the fiber-optics within the catheter. Kinking and bending of the catheter can cause damage. While connecting, ensure the proximal catheter segment is straight and aligned with the DOC. Never attempt to connect and operate the catheter while the catheter remains coiled within the hoop.
- Do not kink, sharply bend, pinch, or crush the Dragonfly™ Imaging Catheters at any time.
- The Dragonfly™ Imaging Catheters have no user serviceable parts. Do not attempt to repair or alter any part of the catheter assembly as provided.
- If you want to make measurements on files that will be exported to standard formats, you must make the measurements BEFORE exporting the images. Using non-OCT software to measure standard format images will not produce accurate measurements.
- Do not use images that have been exported to JPEG or Compressed AVI formats for clinical decision making. These formats use compression methods that may degrade the image quality.
- Artifacts may result in misrepresentation of L-mode data, so L-mode is not recommended for quantification of clinical information.
- It is the user’s responsibility to confirm the lumen contours of all the frames within the reference segment, and to make adjustments if necessary. Red frames indicate low confidence in the detected contours.
- Deleted files cannot be restored. After files have been deleted, they can only be imported back to your system from your archived copies.
- Restoring factory default settings resets ALL user-entered configuration values except the date and time. This button should be used only under the direction of qualified service personnel.
MAT-2309288 v1.0