Author + information
- Louis-Philippe Riel1,
- Manuel Charlebois-Ménard1,
- Steven Dion1,
- Stéphane Rinfret2,
- Jean-FranÃ§ois Tanguay3,
- Marie-Élaine Clavet3,
- Marie-Jeanne Bertrand3,
- Pascale Geoffroy3,
- Simon Berube4,
- Marc-Antoine Despatis4,
- Marianne Brodmann5,
- Éric Thérèse6,
- Andrew Benko4,
- Louis-Georges Guy7,
- Guy LeClerc8,
- Madeleine Chagnon8 and
- Martin Brouillette1
- 1SoundBite Medical Solutions, Montreal, Quebec, Canada
- 2McGill University Health Centre (MUHC), Montreal, Quebec, Canada
- 3Montreal Heart Institute, Montreal, Quebec, Canada
- 4Sherbrooke University Hospital (CHUS), Sherbrooke, Quebec, Canada
- 5Medical University Graz, Graz, Austria
- 6Montreal University Hospital (CHUM), Montreal, Quebec, Canada
- 7AccelLAB, Inc., Montreal, Quebec, Canada
- 8AccelLAB, Montreal, Quebec, Canada
Shock waves have successfully been used in various medical therapies. We use a novel generator to generate shock waves that are focused into the proximal end of a guidewire, referred to as the ShockWire. The shock waves then propagate to the distal tip of the ShockWire, which facilitate device placement into calcified and/or fibrotic chronic total occlusions (CTO). The purpose of this study was to evaluate the acute safety and acute technical performance of this system when used to access and deliver energy to epicardial coronary arteries during PCI in a normal porcine model.
Prototype 0.014 inch coronary ShockWires were used as test articles and MiracleBros 12 guidewires were used as control articles. N=6 pigs were treated, N=4 with the test articles and N=2 with the control. In all cases a Corsair microcatheter was used to place the article within a coronary artery, where the catheter was withdrawn to expose the distal tip of the article for about 3 minutes. Three coronary arteries were treated per animal: for the ShockWire 2 arteries were teated at full power, while 1 artery was treated without power. Device safety was evaluated by: ECG, pre- and post-treatment angiographic analysis, blood sample analysis, main organ necropsy and histology of treated arteries. Technical performance was evaluated from operator assessment of: compatibility with support device, pushability/pullability, radiopacity, tip shapeability and flexibility, endurance.
No change was noted on ECG during test article evaluation. Blood tests were under the limit of detection for Troponin and normal for both Haptoglobin and CK-MB. No microscopic changes during gross organ necroscopy were related to the treatment. The histological changes seen with the test article were barely perceptible microscopicaly and only affected a small portion of the artery. The average technical performance was ranked as excellent.
The ShockWire used during this study appears to be safe when used acutely; all animals tolerated the procedure well and there were no observed adverse events. No safety or technical performance differences were observed between the ShockWire used with and without energy activation.
OTHER: Pre-Clinical/First In-Human Studies