PIUR IMAGING has presented its first working prototype of a sensor-based tomographic ultrasound solution last week at the Charing Cross Symposium in London. The innovation has been developed to provide mobile and inexpensive 3D image diagnostics and ultrasound-guided interventions to healthcare providers around the world, including those that currently lack access to advanced imaging technologies.
The wireless sensor can be clipped onto any ultrasound transducer, allowing doctors to upgrade their standard duplex ultrasound scanners to high-resolution 3D-imaging systems. It can produce quantifiable tomographic images without the need for an external position tracking device, and in the future, provide ultrasound guidance during clinical interventions.
Ultrasound is a widely used imaging technology due to its differentiated properties from other imaging modalities – affordable price, availability, safety, and real-time capabilities. Ultrasound is therefore the imaging technology of choice for many clinical fields, including vascular, thyroid, and nerve diagnostics. Its role in the diagnostic and interventional markets is further growing due to increasing price pressure and safety concerns of healthcare providers. Before PIUR´s tomographic ultrasound system “PIUR tUS” was launched about a year ago, ultrasound was mainly limited to two-dimensional imaging capabilities. With the exception of certain cardiac and pre-natal imaging scenarios for which three-dimensional ultrasound technologies had already existed, patients had to be sent to Computed Tomography (CT) or Magnetic Resonance (MR) scanning to acquire three-dimensional images for comprehensive diagnostics and treatment decisions.
“PIUR tUS bridges the gap between two-dimensional ultrasound and alternative three-dimensional imaging modalities, while combining the benefits of each technology and eliminating most of their drawbacks,” says Robert Bauer, co-founder and CTO of PIUR IMAGING. PIUR tUS is a safe and cost-effective solution for three-dimensional diagnostic imaging without the need for ionizing radiation and nephrotoxic contrast agents. It extends any third-party ultrasound scanner with 3D capabilities, no matter if it is built by GE, Siemens, or any other vendor on the market. All that is needed is a digital video output to assure high-resolution imaging.
“A huge advantage over standard 3D-ultrasound technologies that are sometimes built into high-end ultrasound machines is the independence of the ultrasound transducer,” says Bauer. While built-in 3D solutions are usually based on special matrix transducers with a limited frequency range, PIUR tUS produces tomographic images with the best-suited ultrasound transducer for the currently relevant clinical scenario. “Tomographic images can be produced with a curved array transducer, if depth is required, or with a high-frequency linear transducer, if high resolution is required.” The images are fully quantifiable and can be analyzed as multi-planar reconstructions or as volume renderings. Examples for its use are follow-ups of Endovascular Aneurysm Repairs or the diagnostics of peripheral arterial disease in the lower limb. In both cases, PIUR tUS is a safe alternative for CT or catheter angiography that expose patients to risks due to radiation and nephrotoxic contrast agents. Its 3D vascular mapping capabilities allow better planning of interventions, improve communication among doctors, and enable complete documentation of ultrasound examinations.
“The sensor-based solution will be a considerably more user-friendly and more flexible advancement of the current PIUR tUS system and can also be directly integrated into third-party ultrasound scanners,” says Bauer. The solution uses a wireless sensor that is clipped onto a standard transducer to create quantifiably tomographic ultrasound images. High-end image processing algorithms allow accurate compounding of volumes, even if images are acquired with non-linear scans or non-constant velocity, which is a common situation in routine clinical use. Therefore, complete arms and legs can be imaged and analyzed with the PIUR technology in seconds and for a price that is significantly less than that of a CT or MR.
The technology has been developed together with ImFusion GmbH (Munich, Germany), ACMIT GmbH (Wiener Neustadt, Austria), and the Otto-von-Guericke University (Magdeburg, Germany) as part of a Horizon 2020 project that was sponsored by the European Commission. Several studies evaluating its accuracy and benefits during clinical use are currently ongoing at several European hospitals under the lead of the University of Manchester and Independent Vascular Systems Ltd. (Manchester, UK), a company specialized in vascular ultrasound diagnostics.
“We believe our sensor-based tomographic ultrasound solution can be a game changer in the diagnostic imaging and interventional fields,” says Frederik Bender, co-founder and CEO of PIUR IMAGING. “We are in ongoing discussions with several medical device companies to jointly bring the technology to a level where, in addition to diagnostic purposes, it can be used for tomographic ultrasound guided interventions. Our vision is to create a solution that enables doctors to navigate needles for biopsies or ablation of tumors faster and more accurately, and place stents without the need for C-arm suites. This will have a huge impact, especially in markets like Brazil or India where access to expensive healthcare equipment might be limited outside the urban areas. Our technology is mobile, inexpensive and can provide rural areas with access to advanced diagnostic imaging possibilities.”
Dr. Adriano Souza, vascular surgeon and director of Ecocenter, a center specialized in vascular ultrasound in Belo Horizonte, confirms this statement for his home market of Brazil: “Brazil is a growing market in which 90% of medical imaging equipment is imported and only 25% of its population is covered by healthcare insurance. Large diagnostic imaging services belong to a small number of powerful bank-led groups, and we see a centralization in large cities, mainly in the south and southeast. A major challenge is to make 3D-imaging technologies available for a greater number of patients. In my opinion, the PIUR tUS system can offer reliable vascular diagnostics to a large patient population because it is inexpensive and works with most of the available ultrasound scanners on the market.”
While the prototype of the patented sensor solution can already produce tomographic ultrasound images, the company still needs to finalize the hardware design and regulatory requirements. The product should become market-ready and certified in 2019.