The company’s core technology provides for an image-guided interventional device that seeks to significantly improve both the safety and efficacy of millions of procedures performed each year in the areas of radiology, cardiology, interventional oncology, and urology. The company expects to launch its first product, Vu-Path, in late 2016 under a 510(k) class II submission.
Physicians use several different techniques to perform minimally-invasive procedures, such as line placements, aspirations, and therapeutic injections. Interventional options include open surgery or image guidance by surface ultrasound, CT, X-Ray, and MRI. However, these techniques can be expensive, inconvenient, risky, and may not be usable for the critically ill. For example, current surface ultrasound systems are difficult to maneuver, do not apply to “difficult cases,” and inadequately detect the tip of the needle or catheter, potentially leading to puncture of nearby structures and organs. The high cost and substantial training requirements of existing imaging solutions have greatly limited acceptance.
Vu-Path addresses the current unmet need by quickly, safely, and precisely accessing organs and internal structures. The patented core technology is unique in integrating a forward-viewing imaging element that allows accurate and precise placement of a probe’s tip. Perceptive’s first product, Vu-Path, will be the first intracorporeal (“within the body”) ultrasound probe that does not occupy a lumen in the body (such as the esophagus). This composite probe combines ultrasound imaging with a versatile portal that can be used for introducer needles, biopsy needles, guide wires, or the delivery of therapeutics. By replacing surface ultrasound, CT, X-Ray, and MRI in complex surgical and percutaneous procedures, Vu-Path will shorten procedural times while reducing staff needs, facility requirements, and equipment costs.