OSTIAL PRO® Stent Positioning System allows easier assessment of coronary or renal ostia, improving the accuracy of stent positioning in AO lesions:

• Unique design provides three dimensional visual and tactile feedback

• Excellent pushability and strong pullback capabilities

• Compatible with 6, 7, and 8 French guiding catheters

OSTIAL PRO® Stent Positioning System helps avoid potential complications.

Once positioned against the ostium, the OSTIAL PRO® Stent Positioning System:

• Helps prevent deep seating of the guide catheter1

• May decrease risk of dissection by minimizing guide catheter tip trauma

• Facilitates precise stent positioning in the ostium to help reduce the risk of distal and proximal lesion stent deployment and the need for more costly reinterventions

The OSTIAL PRO® Stent Positioning System enables more accurate stent placement, which can help reduce:

• The length of procedures

• Fluoroscopy and radiation exposure

• Use of contrast (important for preserving renal function)

The Challenge of Stenting Aorto-Ostial Lesions

• Aorto-ostial (AO) stenting accounts for an estimated 5%-7% of coronary interventions and more than 90% of renal artery interventions.

• AO lesions are more likely to be associated with suboptimal angiographic results due to lesion rigidity and elastic recoil, and have higher rates of target lesion revascularization.

• Conventional angiographic landmarks used during stenting of AO lesions are often ambiguous and/or misleading, making accurate stent positioning extremely difficult.

• In a retrospective study of 100 patients in whom stents were placed using angiographic landmarks, correct stent positioning was achieved in only 46% of cases.

• This device was associated with decreased procedure time, radiation exposure and reduced use of contrast.

Yellow marker

permits positive identification and differentiation of the Ostial Pro® Stent Positioning System from other wires.

Nitinol wire

0.018 inch wire allows greater pushability and strong pullback capabilities.

15 mm leg span

accommodates ostia.

Nitinol gold-plated legs

allow greater opacification to help identify the plane of the ostium.

Flexible distal wire

The 4 cm distal end is ground down to 0.014 inches and heat-treated to allow more flexibility to prevent straightening of the guiding catheter curve, while retaining push/pull characteristics.

Flexible cylinder

Longitudinal opening allows use with 6, 7, or 8 French guiding catheters.

Cylinder/wire

connection

Tapered cylinder

permits easy pullback into the guide.

Overall length of 127 cm

permits use with any guide that is ≤100 cm in length.

Learn how the Ostial PRO Stent Positioning can be used to facilitate the positioning of aorto-ostial stents for more accurate placement.

CONTRAINDICATIONS:

If other interventional devices are used in conjunction with the Ostial PRO Stent Positioning System, refer to specific manufacturer’s product labeling for intended use, contraindications and potential complications associated with that device.

PRECAUTIONS:

• For single use only. Do not resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure, which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

• Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

• Device is sterile if the package is dry, unopened and undamaged. Do not use if sterile barrier is damaged.

• The device must be used prior to the expiration date.

• Discard device if mishandling has caused possible damage or contamination.

• This device should be stored in a clean, dry location at room temperature.

• This device has been sterilized with ethylene oxide gas.

• Inspect the Ostial PRO Stent Positioning System prior to use for any bends or kinks. Any Ostial PRO Stent Positioning System damage may decrease the desired performance characteristics.

• These Instructions For Use are designed to serve only as a general guideline. They are not intended to supersede institutional protocols or professional clinical judgment concerning patient care.

WARNING:

If extended procedure is required (greater than 30 minutes), it is recommended to not load the Ostial PRO Stent Positioning System into the guiding catheter until it is needed to aid in the placement of the stent. For these procedures, utilize the “Front Loading” steps for the Ostial PRO Stent Positioning System introduction into the guiding catheter.

b. Front Loading

i. Remove the blue introducer tube from the plastic shipping hoop.

ii. Load the Ostial PRO Stent Positioning System into the introducer tube by inserting the proximal (yellow) end of the Ostial PRO Stent Positioning System wire into the blue introducer.

iii. Pull the Ostial PRO wire through the introducer until the Ostial PRO Stent Positioning System body is positioned inside the diameter of the blue introducer.

iv. If a guide wire is engaged in the guiding catheter, slide the blue introducer tube over the proximal end of the guide wire.

v. Insert the introducer tube and Ostial PRO Stent Positioning System together into the proximal end of the Tuohy-Borst adaptor.

vi. Slide the blue introducer tube through the Tuohy-Borst until it contacts the proximal end of the hub on the guiding catheter. Blue introducer will stop.

vii. At this time, push the Ostial PRO Stent Positioning System forward until it passes out the distal end of the blue introducer tube. The Ostial PRO Stent Positioning System will now be in the guiding catheter.

viii. The Ostial PRO Stent Positioning System can now be slid distally until it is proximal to the primary curve of the guiding catheter.

5. Advance a 0.014”-0.025” (.35 mm - .64 mm) guide wire into the Tuohy-Borst through the guiding catheter crossing the ostial lesion and positioned in the distal portion of the target vessel.

6. Advance the stent catheter system through the Tuohy-Borst over the guide wire until the stent catheter system is distal to the diseased area to be treated.

7. Disengage the guiding catheter from the ostium of the vessel, pulling the guide tip back approximately 3-5 mm and confirm that the guiding catheter is in the aorta using a small test injection of contrast.

8. While holding the stent catheter system and guide wire in a stable position, gently push the Ostial PRO Stent Positioning System forward until the gold plated distal feet expand into an open position, using fluoroscopic guidance.

9. Push the guiding catheter and Ostial PRO Stent Positioning System, together as one single unit, forward until the gold-plated feet are clearly in contact with the aortic wall. Inject contrast medium to confirm the guiding catheter, Ostial PRO Stent Positioning System, and lesion positions (“Power Position”).

Adverse reactions include but are not limited to: emboli, hemorrhage, ischemia, vasospasm, vessel damage, and neurological defects including stroke and death.