Drug-coated balloons
In.pact 018
A sterile, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip, and to simultaneously release a drug intended to inhibit restenosis; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single-lumen. This is a single-use device.
FDA clearances
- PMA P140010 February 2020
Procedures that use drug-coated balloons
Frequently asked questions
What is In.pact 018 used for?
A sterile, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip, and to simultaneously release a drug intended to inhibit restenosis; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single-lumen. This is a single-use device.
Who makes In.pact 018?
In.pact 018 is made by Medtronic, Inc.. It is listed under drug-coated balloons in our device library.
What sizes does In.pact 018 come in?
Sizes listed for In.pact 018: Outer Diameter: 4–6 mm; Length: 40–150 mm; Balloon Diameter: 4–7 mm. Confirm availability with the manufacturer's instructions for use.
Is In.pact 018 MRI safe?
The FDA device database entry for In.pact 018 does not state its MRI safety status. Check the labeling before MRI.
Is In.pact 018 FDA cleared?
In.pact 018 is covered by FDA submission P140010.
How do I contact a Medtronic, Inc. sales representative?
Medtronic, Inc. has not listed representatives on LA Vascular yet. Visit the Medtronic, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.