Ellipsys™ vascular access system and IN.PACT™ AV drug-coated balloon
Important safety information
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Ellipsys vascular access system
Contraindications
The Ellipsys™ system is not indicated for patients with target blood vessels that are too small to be used with the Ellipsys™ system.
Warnings
- The Ellipsys™ system has only been studied for the creation of an arteriovenous fistula (AV Fistula or AVF) using the proximal radial artery and the adjacent perforating vein.
- The Ellipsys™ system is not intended to treat patients with significant vascular disease or blockage in the target vessels.
- It is recommended that a follow-up evaluation is performed to determine if any additional treatment is needed.
Precautions
- Additional treatment may be needed to increase and direct blood flow into the target vein and to keep the AVF open.
- Short-term or long-term treatment to slow down or stop the coagulation of blood may be needed, as determined by your doctor.
Potential Adverse Events
As with any procedure, there is a chance that complications may occur. The following are some of the risks that may be associated with the creation or maintenance of your arteriovenous fistula. Discuss any questions you may have with your doctor.
Risks include but are not limited to the following:
- Total blockage, partial blockage or narrowing of the fistula or outflow vein next to the fistula
- Narrowing of the central AVF outflow vein which requires treatment
- Vein may not get big enough, after the AVF is created
- If embolization coil is used to direct blood flow, the coil may not completely tie off the vessels, which could require an additional coil
- Lack of blood flow to the hand (Steal Syndrome), which can cause symptoms including but not limited to: hand numbness, pain, coldness, and/or weakness
- Solid swelling of clotted blood within the arm
- Infection or other complications
- Need for additional procedures to help access the AVF for dialysis
- Need for additional procedures to help the vein get bigger after the AVF is created
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Important Information: Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device.
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IN.PACT AV drug-coated balloon
Potential Adverse Effects Associated with the IN.PACT AV DCB
Potential adverse effects that may be associated with balloon catheterization may include, but are not limited to, the following:
- Abrupt vessel closure
- Allergic reaction
- Arrhythmias
- Arterial or venous aneurysm
- Arterial or venous thrombosis
- Death
- Dissection
- Embolization
- Hematoma
- Hemorrhage
- Hypotension/hypertension
- Ischemia or infarction of tissue/organ
- Infection
- Loss of permanent access
- Pain
- Perforation or rupture of the artery or vein
- Pseudoaneurysm
- Restenosis of the dilated vessel
- Shock
- Stroke
- Vessel spasms or recoil
Although systemic effects are not anticipated, potential adverse effects that may be unique to the Paclitaxel drug coating include, but are not limited to, the following:
- Allergic/immunologic reaction
- Alopecia
- Anemia
- Gastrointestinal symptoms
- Hematologic dyscrasia (including leucopenia, neutropenia, thrombocytopenia)
- Hepatic enzyme changes
- Histologic changes in vessel wall, including inflammation, cellular damage, or necrosis
- Myalgia/arthralgia
- Myelosuppression
- Peripheral neuropathy
IN.PACT AV: Summary of Clinical Information
The IN.PACT AV drug-coated balloon was evaluated in the IN.PACT AV Access Study. The IN.PACT AV Access Study enrolled 330 patients in the United States, Japan, and New Zealand. The clinical trial conclusively demonstrated safety and effectiveness of the IN.PACT AV DCB when compared to conventional balloon catheters. The results of this study showed that the IN.PACT AV DCB is safe and effective for treating restenotic obstructive lesions of an AV both de novo and restenotic obstructive lesions. Your doctor can explain the risks and benefits that are specific to you.
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UC202405894 EN
