Skip to Content
About Abbott
Contact
United States | eng
Country Language
CARDIOVASCULAR
United States | eng
Country Language

Diamondback 360™
Precision

Coronary Orbital Atherectomy System

Diamondback 360 Coronary Orbital Atherectomy System

Clinical Trials

Clinical trials sponsored by legacy—CSI. Counts updated 07Jul2021—subject to change (includes ORBIT I, ORBIT II, COAST, Coronary Flow Reserve, and ECLIPSE).

*All ORBIT I subjects were followed for 6 months; 33 subjects were followed for 5 years at 1 institution.

ORBIT I1

The ORBIT I trial was a first-in-human prospective, non-randomized, multi-center, feasibility study that evaluated the safety, performance and effectiveness of OAS.

  • OAS is an effective tool for modifying calcified lesions to facilitate optimal stent placement.
  • ORBIT I reported high device success rate of 98% and a procedural success rate (defined as final residual stenosis of less than 20% after stenting) of 94%.

ORBIT II2

The ORBIT II pivotal trial was a prospective, multi-center study conducted in the U.S. that evaluated patients with severely calcified coronary lesions treated with Diamondback 360™ Coronary OAS prior to stent implantation.

  • ORBIT II met the primary safety and efficacy endpoints by a significant margin.2
  • ORBIT II demonstrated long term durable results with a low target lesion revascularization (TLR) rate of 3.4% at 1 year in the drug-eluting stent (DES) subset (N=389/443).4 

Study Design2

  • 443 patients with severely calcified lesions were enrolled at 49 U.S. Sites
  • Designed to evaluate the safety and efficacy of the Diamondback 360™ Coronary OAS Classic Crown
  • Primary Safety Endpoint: Major adverse cardiac events (MACE) at 30 days
  • Primary Efficacy Endpoint: Procedural Success defined as success in facilitating stent delivery with a residual stenosis of <50% and without the occurrence of an in-hospital MACE

PATIENT POPULATION2

 N=443
History of Diabetes36.1%
History of CABG14.7%
History of Dyslipidemia91.9%
History of Hypertension91.6%
Smoker (current or previous)66.1%

 

STUDY RESULT2

Procedural Success88.9%
Successful Stent Delivery97.7%
Less than 50% Residual Stenosis98.6%
Freedom from in-hospital MACE90.2%

 

30-Day Outcomes3

Diamondback 360 OAS 30 Day Outcomes

1-Year Outcomes3

Diamondback 360 OAS 1-Year Outcomes

ECLIPSE5

The ECLIPSE trial was a prospective, randomized, multicenter trial designed to evaluate two different vessel preparation strategies in severely calcified coronary artery lesions.

  • Intravascular imaging guidance during PCI of severely calcified lesions was associated with improved 2-year clinical outcomes compared with angiography guidance alone, whether orbital atherectomy or conventional balloon angioplasty was used for vessel preparation prior to DES.6
  • Compared with conventional balloon angioplasty, calcium modification was greater in the orbital atherectomy group (greater number, total length, and maximal depth of calcium fractures), especially in lesions with thicker calcium.7

ECLIPSE Trial: A Closer Look

An interview with Dr. Ajay J. Kirtane, hosted by Dr. Ethan Korngold, CMO & DVP, Global Medical Affairs, Vascular, Abbott.

Imaging Substudy: TVF at 2 Years6

Imaging Substudy: TVF at 2 Years

*Adjusted for IVI vs. angiography guidance, baseline clinical variables (age, sex, diabetes, current smoker, prior PCI, prior CABG, prior MI, h/o PVD, eGFR, hemodialysis, and presentation with ACS), baseline core laboratory angiographic variables (# lesions treated, any LM or LAD treated, smallest RVD, smallest MLD, and max calcium length), and randomization to OA vs. BA, using inverse propensity score weighting with a robust variance estimator.

Calcium Fracture with OA Effect7

Calcium Fracture without OA Effect7

Calcium fracture with and without OA effect

Optical coherence tomography (OCT) appearance of calcium fracture with and without orbital atherectomy (OA) effect. Left, Calcium fracture with OA effect: the pre-percutaneous coronary intervention (pre-PCI) OCT image shows thick eccentric calcium. The post-OA image shows a round, concave-shaped calcium surface without a remaining fibrous cap, indicating OA calcium modification (red outline). The final post-stent image shows calcium fracture at the site of OA effect modification. Right, Calcium fracture without OA effect: The pre-PCI OCT image shows concentric calcium. No OA effect was observed on the final stent image. The final post-stent OCT shows 2 calcium fractures where the calcium thickness was thin.

Study Design

  • 2005 patients with 2492 lesions were randomly assigned to lesion preparation with orbital atherectomy (1008 patients with 1250 lesions) or balloon angioplasty (997 patients with 1242 lesions) before stent implantation.5
  • Patients selected for 1:1 randomization in ECLIPSE had severe calcium, primarily confirmed using angiography, and either orbital atherectomy or conventional balloon angioplasty were acceptable treatment options.8 Patients were excluded if the investigator felt the target lesion absolutely required atherectomy or was absolutely contraindicated for atherectomy.8
  • Intravascular imaging (IVI) guidance with either OCT or intravascular ultrasound (IVUS) during PCI per operator discretion was used in 1,246 patients (62.1%) (OCT in 819 and/or IVUS in 513).9

Learn more about how OCT-guided PCI improved procedural outcomes and safety results as demonstrated in ILUMIEN IV10

COAST11

The COAST trial was a prospective, multicenter, single-arm study that enrolled 100 patients with severely calcified de novo coronary lesions at 17 sites in the US and Japan.

Pre-stent preparation of severely calcified lesions using the novel Micro Crown OAS resulted in similar rates of procedural success and freedom from MACE compared with the Classic Crown OAS.

References

  1. Parikh K, Chandra P, Choksi N, et al. Safety and Feasibility of Orbital Atherectomy for the Treatment of Calcified Coronary Lesions: the ORBIT I Trial. Catheter Cardiovasc Interv. 2013;81(7):1134-1139.
  2. Chambers JW, Feldman RL, Himmelstein SI, et al. Pivotal Trial to Evaluate the Safety and Efficacy of the Orbital Atherectomy System in Treating De Novo, Severely Calcified Lesions (ORBIT II). JACC Cardiovasc Interv. 2014;7(5):510-518.
  3. Lee MS, Gordin JS, Stone GW, et al. Orbital and Rotational Atherectomy during Percutaneous Coronary Intervention for Coronary Artery Calcification. Cardiovasc Revasc Med. 2017;18(4):261-264. 
  4. Généreux P, Lee AC, Kim CY, et al. Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial). Am J Cardiol. 2015;115(12):1685-1690.
  5. Kirtane AJ, Généreux P, Lewis B, et al. Orbital Atherectomy versus Balloon Angioplasty before Drug-Eluting Stent Implantation in Severely Calcified Lesions Eligible for both Treatment Strategies (ECLIPSE): a Multicentre, Open-Label, Randomised Trial. Lancet. 2025;405(10486):1240-1251.
  6. Stone GW. ECLIPSE: Two-Year Outcomes from a Large-scale, Randomized Trial of Orbital Atherectomy vs. Conventional Balloon Angioplasty in Severely Calcified Coronary Arteries Prior to DES Implantation. Presented at CRT 2026.
  7. Maehara A, Kirtane AJ, Généreux P, et al. Calcium Modification After Orbital Atherectomy and Balloon Angioplasty in Severely Calcified Lesions: The ECLIPSE OCT Substudy. Circ Cardiovasc Interv. 2026;19(1):e015588.
  8. Généreux P, Kirtane AJ, Kandzari DE, et al. Randomized Evaluation of Vessel Preparation with Orbital Atherectomy prior to Drug-Eluting Stent Implantation in Severely Calcified Coronary Artery Lesions: Design and Rationale of the ECLIPSE Trial. Am Heart J. 2022 Jul;249:1-11. 
  9. Stone GW, Généreux P, Maehara A, et al. Intravascular Imaging vs Angiography Guidance for PCI of Severely Calcified Lesions: The ECLIPSE Trial. JACC Cardiovasc Interv. 2025;18(19):2338 -2351.
  10. Ali ZA, Landmesser U, Maehara A, et al. Optical Coherence Tomography–Guided versus Angiography-Guided PCI. NEJM. 2023 Aug;389:1466-1476.
  11. Redfors B, Sharma SK, Saito S, et al. Novel Micro Crown Orbital Atherectomy for Severe Lesion Calcification: Coronary Orbital Atherectomy System Study (COAST). Circ Cardiovasc Interv. 2020 Aug;13(8):e008993.

MAT-2643369 v1.0

Important Safety Information

Diamondback 360™ and Diamondback 360 Precision™ Coronary Orbital Atherectomy System

rx-only-logo

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

rx-only-logo

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