Surmodics™ Pounce™ Thrombectomy System

Indication for use/intended use

The Pounce™ Thrombectomy System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature.

The Pounce™ Thrombectomy System is indicated for use in vessels ranging from 3.5 mm to 6 mm in diameter.

Contraindications

  • The device is not intended for venous applications.
  • The device is not intended for peripheral vasculature dilatation.
  • The device is not for coronary or neurovascular use.
  • The device is contraindicated for use in patients who cannot receive recommended intravenous anticoagulant therapy.
  • The safety and effectiveness of the device has not been established in pediatric patients (<18 years of age).
  • The device is not intended to be deployed in vessels with previously implanted devices.

Surmodics™ Pounce™ LP Thrombectomy System

Indication for use/intended use

The Pounce™ Thrombectomy System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature.

The Pounce™ LP Thrombectomy System is indicated for use in vessels ranging from 2 mm to 4 mm in diameter.

Contraindications

  • The device is not intended for venous applications.
  • The device is not intended for peripheral vasculature dilatation.
  • The device is not for coronary or neurovascular use.
  • The device is contraindicated for use in patients who cannot receive recommended intravenous anticoagulant therapy.
  • The safety and effectiveness of the device has not been established in pediatric patients (<18 years of age).
  • The device is not intended to be deployed in vessels with previously implanted devices.

The opinions, clinical and otherwise, presented here are informational only. The opinions are those of the presenter only and do not necessarily reflect the views of Surmodics. Results discussed from use of Surmodics or other products may not be predictive of all patients and may vary depending on differing patient characteristics.

Sublime™ Radial Access Guide Sheath

INDICATIONS FOR USE

The Guide Sheath is intended to introduce therapeutic or diagnostic devices into the vasculature, excluding the coronary and neurovasculature.

Caution: Federal (US) law restricts this device to sale by or on the order of a physician. Please refer to Instructions for Use for indications, contraindications, warnings, and precautions.

Sublime™ Radial Access .014 and .018 RX PTA Dilatation Catheters

INDICATIONS FOR USE

The Sublime™ Radial Access .014 and .018 RX PTA Dilatation Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) dilation of peripheral vasculature stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

CONTRAINDICATIONS

The Sublime™ Radial Access .014 and .018 RX PTA Dilatation Catheters are contraindicated for use in the coronary arteries and the neurovasculature.

Caution: Federal (US) law restricts this device to sale by or on the order of a physician. Please refer to Instructions for Use for indications, contraindications, warnings, and precautions.

Sublime™ .014, .018, and .035 Microcatheters

INDICATIONS FOR USE

The Sublime™ Microcatheter is intended to access the peripheral vasculature in order to facilitate the placement and/or the exchange of guidewires. The Sublime™ Microcatheter is also intended to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Caution: Federal (US) law restricts these devices to sale by or on the order of a physician. Please refer to Instructions for Use for indications, contraindications, warnings, and precautions.

The opinions, clinical and otherwise, presented here are informational only. The opinions are those of the presenter only and do not necessarily reflect the views of Surmodics. Results discussed from use of Surmodics or other products may not be predictive of all patients and may vary depending on differing patient characteristics.