Balloon Distal Access Catheters
PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature
Indications for Use
The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral transluminal angioplasty and for capture and containment of embolic material during angioplasty for the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries. The Angioslide PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature is not intended for use in the renal, cerebral, coronary or carotid vasculature.
Key Specifications
- Over-the-wire dual lumen catheter
- Foldable balloon located near distal atraumatic soft tip
- Inflation lumen accessed via inflation port
- Guidewire lumen compatible with max. 0.035" guidewire
- Two radiopaque markers for balloon positioning relative to stenosis
- Balloon provides inflatable segment of known diameter and length at specified pressure
- Shaft comprises outer shaft and inner shaft
- Distal balloon end connected to inner shaft, proximal to outer shaft
- Pulling knob and handle grip mechanism to fold balloon inwards for embolic capture
- Embolic capture feature: single-use suction mechanism creating negative pressure via inward folding for debris containment and removal
- Balloon size and diameter printed on strain relief
- Catheter overall length, balloon nominal pressure, rated burst pressure, balloon sizes, compliance, guidewire compatibility (0.035"), and sheath compatibility indicated on package label
- Compatible with 0.035" guidewire
- Proximal vessel occlusion via inflatable balloon for embolic material containment
- Tensile strength requirements: various components >10N or >15N force at break
- Balloon inflation/deflation time <3 seconds
- Distal tip smooth, rounded, tapered
- Minimum stroke length >70% of balloon working length
- Balloon passes through identified introducer sheath when folded
- No permanent deformations in tortuous anatomy
- Distal flow observed in uninflated/deflated state, occlusion in inflated state
- Sterilized by ethylene oxide (EtO) with SAL of 1x10^-6
- Non-pyrogenic: endotoxin limit <0.5 EU/mL
- Validated shelf life: 3 years
Description
The PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature is an over-the-wire dual lumen catheter with a foldable balloon near the distal atraumatic soft tip. It features an inflation lumen and a guidewire lumen (max. 0.035"), radiopaque markers for positioning, and a mechanism to fold the balloon inwards, creating negative pressure for embolic debris capture and removal during peripheral angioplasty procedures.