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FLASH™ Ostial System

Available for both coronary and peripheral indications. The FLASH™ Ostial System Dual-Balloon Angioplasty Catheter is designed to help overcome challenges of aorto-ostial stenting.  
Product Description
FLASH™ Ostial System is designed to conform to the ostium during stent post-dilatation and angioplasty. The dual balloon design enables the physician to achieve stent wall apposition after post-dilatation, and stability during angioplasty of challenging ostial lesions. The FLASH™ Ostial System is available for both coronary and peripheral indications.

Procedural Steps: Stent Post-Dilatation

Align Markers

  • Mid-Marker: at the ostiu
  • Distal Marker: within the stent
  • Inflate Distal Balloon
  • Inflate to nominal pressure

Flash It With Proximal Balloon

  • Inflate using 1cc syringe
  • 1cc for FLASH
  • 0.4cc for FLASHmini

Final Result

Refer to the IFU for detailed procedure steps.

The FLASH™ Ostial System is manufactured by Ostial Corporation and distributed by Cardinal Health. Indications for use and important safety information can be found at www.ostialcorp.com.

Clinical Resources

Documentation

Clinical Articles

Treatment of Ostial Renal Artery Stenosis with Stenting Followed by Flared Ostial Balloon
Harit Desai DO, George JC. Vascular Disease Management 2012; 9;9: 146-148.

Stenting of the Vertebral Artery Origin with Ostium Dilation: Technical Note.
Dumont TM, Kan P, Snyder KV, Hopkins LN, Levy EI, Siddiqui AH. J Neurointervent Surg 2012;0: 1-5.

High Incidence of Inaccurate Stent Placement in the Treatment of Coronary Aorto-Ostial Disease
Dishmon DA et al. Journal of Invasive Cardiology 2011; 23; 8.

Ordering Information

In the United States, fax your order to 877.933.0133, email GMB-ACI-Customer-Service@cardinalhealth.com, or call 877.700.6969. Outside of the United States, contact Ostial Corporation.

The Flash Ostial System Dual Balloon Angioplasty Catheter includes:

  • (1) Dual-balloon angioplasty cathetery
  • (1) 10 ml syringe
  • (1) 1 ml syringe

 

Distal Balloon Length

FLASHmini

FLASH

8mm

12mm

17mm

Distal Balloon
Diameter

3.0

OCB3008BA+

 

 

3.5

OCB3508BA+

 

 

4.0

OCB4008BA+

OCB4014BA

 

4.5

OCB4508BA+

OCB4514BA

 

5.0

 

OCB5014BA

OCB5019BA

6.0

 

OAB6014BA*

OAB6019BA*

6.0   OTW6012BA^  

7.0

 

 

OTW7012BA^

 

7.0

 

 

OTW7017BA^

* 6mm and 7mm models are indicated for peripheral use only
+ FLASHmini models are indicated for coronary use only
^ 0.035” OTW compatible

IFU

FLASH™ Ostial System Dual Balloon Angioplasty Catheter for Use in Percutaneous Transluminal Coronary Angioplasty

Indications For Use: The FLASH™ Ostial System is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The FLASH™ Ostial System is also indicated for the post delivery expansion of balloon expandable stents within the coronary vasculature. Contraindications: Unprotected left main coronary artery. Coronary artery spasm in the absence of a significant stenosis. Warnings: Contents are supplied STERILE using radiation (e-beam) and are non-pyrogenic. Do not use if sterile barrier is opened or damaged. This device is intended for single use only. Do not reuse, reprocess or re-sterilize. Balloon and/or catheter integrity may be compromised by reprocessing or re-sterilization and could lead to serious patient injury. When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation. Do not advance or retract the catheter unless the balloons are fully deflated under vacuum. If resistance is felt during manipulation, determine the cause of the resistance before proceeding. Applying excessive pull force to the catheter can result in tip breakage or balloon separation. To reduce the potential for vessel damage, the inflated diameter of the Angioplasty Balloon should approximate the diameter of the vessel or graft just proximal and distal to the stenosis. Do not exceed the rated burst pressure or maximum inflation volume recommended per the compliance table on the product labeling. The rated burst pressure is based on the results of in vitro testing. At least 99.9 percent of the balloons, (with a 95 percent confidence) will not burst at or below their rated burst pressure. To prevent over pressurization, use of a pressure monitoring device is recommended for Angioplasty Balloon inflation. To reduce the potential for air embolus into the vessel, use only the recommended balloon inflation medium (50% Contrast / 50%Sterile Saline). Never use air or other gaseous medium to inflate the balloon. PTCA in patients who are not acceptable candidates for coronary artery bypass graft surgery warrants careful consideration, including possible hemodynamic support during PTCA, as treatment of this patient population carries special risk. The FLASH™ Ostial System is not cleared for expanding balloon expandable stents within the neurovasculature. Precautions: See IFU for a list of Precautions. Potential/Adverse Events: The complications that may result from a balloon dilatation procedure include: death, acute myocardial infarction, acute vessel closure, total occlusion of the coronary artery or bypass graft, coronary vessel dissection, perforation, rupture or injury, restenosis of the dilated vessel, hemorrhage or hematoma, unstable angina, arrhythmias, including ventricular fibrillation, drug reactions, allergic reaction to contrast medium, hypotension, hypertension, infection, coronary artery spasm, arteriovenous fistula, stroke, air embolism and embolization or fragmentation of thrombotic or atherosclerotic material.

FLASH™ Ostial System Dual Balloon Angioplasty System for Use in Peripheral Percutaneous Transluminal Angioplasty

Indications For Use: The FLASH™ Ostial System is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature. Contraindications: There are no known contraindications for the FLASH™ Ostial System. Warnings: Contents are supplied STERILE using radiation (e-beam) and non-pyrogenic. Do not use if sterile barrier is opened or damaged. This device is intended for single use only. Do not reuse, reprocess or re-sterilize. Balloon and/or catheter integrity may be compromised by reprocessing or re-sterilization that could lead to serious patient injury. Use the catheter prior to the "Use By" date specified on the package. When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. If resistance is felt during manipulation, determine the cause of the resistance before proceeding. Applying excessive pull force to the catheter can result in tip breakage or balloon separation. Do not exceed 2.0 lbs when retracting the device into the guide catheter. To reduce the potential for vessel damage, the inflated diameter and length of the balloon should approximate the diameter and length of the vessel or graft just proximal and distal to the stenosis. Do not exceed the maximum burst pressure or maximum inflation volume recommended per the compliance table on the product labeling. To prevent over pressurization, use of a pressure monitoring device is recommended for angioplasty balloon inflation. Use the recommended balloon inflation medium (50% Contrast / 50% Sterile Saline). Never use air or other gaseous medium to inflate the balloon. Precautions: See IFU for a list of Precautions. Potential/Adverse Events: The complications that may result from a balloon dilatation procedure include: additional intervention, allergic reaction to drugs or contrast medium, embolization, hematoma, hemorrhage, inflammation, ischemia, sepsis/ infection, thrombosis, vascular trauma (vessel dissection, spasm, etc.)

See IFU for complete information.