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Updated: Aug 15, 2026

A Rat Carotid Artery Pressure-Controlled Segmental Balloon Injury with Periadventitial Therapeutic Application
06:53

A Rat Carotid Artery Pressure-Controlled Segmental Balloon Injury with Periadventitial Therapeutic Application

Published on: July 9, 2020

Safety and Clinical Performance of Peripherics™ Paclitaxel-Coated Balloon Catheter in Below-the-Knee Arteries: A

Prashant Sarda1, PremChand Gupta2, Pradeep Burli2

  • 1Vascular Surgery, Shri Mahant Indiresh Hospital, Dehradun, IND.

Cureus
|August 14, 2026
PubMed

Insights

The Peripherics™ paclitaxel-coated balloon (PCB) catheter shows promising safety and effectiveness for treating below-the-knee arterial disease. This study found low complication rates and significant clinical improvement in patients within 30 days.

Area of Science:

  • Vascular Surgery
  • Interventional Cardiology
  • Medical Device Technology

Background:

  • Below-the-knee (BTK) arterial disease poses a significant risk of limb loss.
  • Evidence for routine use of paclitaxel-coated balloons (PCBs) in BTK disease is limited.
  • The Peripherics™ PCB catheter is a novel device for treating BTK lesions.

Purpose of the Study:

  • To evaluate the safety and clinical performance of the Peripherics™ PCB catheter.
  • To assess the device in routine clinical practice for BTK arterial disease.
  • To determine the rate of major adverse limb events (MALE) and perioperative death (POD) at 30 days.

Main Methods:

  • Retrospective, observational, multicenter, single-arm, post-market study.
  • Included 70 patients with Rutherford categories III-V BTK arterial disease.
  • Primary safety endpoint: 30-day MALE and POD.

Main Results:

  • 71 Peripherics™ PCB catheters used in 70 patients; high technical and procedural success rates (100% and 97.1%).
  • Mean ankle-brachial index improved significantly post-procedure.
  • Low 30-day MALE and POD rate of 2.9% (1.4% reintervention, 1.4% death).
  • 87% of patients showed clinical improvement (Rutherford class).

Conclusions:

  • The Peripherics™ PCB catheter demonstrated favorable safety and clinical outcomes.
  • Low event rates and significant clinical improvement were observed at 30 days.
  • Supports the use of Peripherics™ PCB for BTK arterial disease treatment.
Abstract

Keywords:
angioplastyballoonendovascular procedureslimb-threatening ischemiapaclitaxelperipheral arterial disease

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