ChannelSense – a minimally invasive and intelligent crossing-atherectomy device for the treatment of critical limb ischaemia

Critical limb ischemia, a severe stage of peripheral artery disease, results from artery blockages due to plaque build-up. It requires immediate treatment to restore blood flow, as it often leads to poor outcomes, including high mortality and amputation rates.

Traditional treatments include revascularization, surgical bypass, or amputation. Recent studies have shown that percutaneous transluminal angioplasty can prevent most limb amputations in patients with lower limb atherosclerotic disease in the United States and Europe.

Versono, in collaboration with Integer, the Translational Medical Device Lab (TMD, NUIG), the Duffy Lab (NUIG), and the Gavin Lab (TUD), developed ChannelSense. This is an innovative chronic total occlusion device designed for minimally invasive treatment of critical limb ischemia.

**Consortium Contributions:**

- **Versono:** Integrated atherectomy and sensing technology, conducted design testing, and worked towards commercialization. They pioneered an ultrasound wire ablation system crucial for treating critical limb ischemia.

- **NUIG:** Focused on digital signal processing and machine learning for lesion characterization, also explored additive manufacturing with patient-specific geometries.

- **TUD:** Developed computational models for ultrasonic guidewires, analyzing transmission, strain, and fatigue under loading.

- **Integer:** Created the peripheral guide aspirating catheter, contributing their expertise as a major medical device manufacturer.

The project completed technical development and integration, culminating in preclinical evaluations to assess safety and efficacy. The final study report aimed to inform future clinical trials and regulatory approval for commercialization in the EU.