The business of diagnosing all vascular diseases includes a certain amount of guesswork on the part of physicians because, until now, they had no real way of assessing the volumetric blood flow rate in vessels. Now, VasSol (Chicago) has launched the first available test to non-invasively quantify the volumetric blood flow rate in vessels, also skipping the potential side effects of any contrast media.
NOVA (Non-invasive Optimal Vessel Analysis) incorporates interactive 3-D images that provide a fully rotatable, 360 degree view of vasculature that allows for precise identification of each vessel for volumetric blood flow calculation. NOVA allows physicians to evaluate entire vasculatures or pinpoint specific areas within a vessel that may be of concern.
VasSol's first application, the NOVA Neuro system, focuses on the neurovascular region, which encompasses the head and neck. Specifically, data gathered via this software helps physicians to diagnose and treat patients who are at risk for or who have suffered from stroke and cerebral aneurysms, as well as those who suffer from neurovascular disease related to chronic medical conditions such as heart disease and diabetes. Numerous other potential applications are in the wings.
"This really provides an opportunity for a physician to wait and do nothing," VasSol CEO Anthony Curcio told Diagnostics & Imaging Week. "They can also determine if medical management is working or successful. Then, there is the ability to monitor patients without concern of sensitivity to gadolinium contrast or the concern of cumulative radiation or concern over an invasive procedure such as angiograms. We like all of the other traditional tests; we don't want to have an argument over whether CT or MRI will prevail. But this is the only modality that gives you the opportunity to measure blood flow."
Simply put, if a physician determines that a vessel is blocked, the next step depending on the location of the blockage might be catheter embolization or an endarterectomy.
"But our bodies have a lot of different back-up systems," Curcio said. "Although the neurovascular system may have a compromise, other vessels can take on extra workload. But how do you know? You can't unless you have quantitative assessment and that's what NOVA provides."
If a physician can determine that other vessels are taking over, surgery or other tests could be avoided.
FDA approved via a 510(k) in 2002, NOVA has been used almost exclusively at the nearby University of Illinois (UC; Chicago) in almost 8,000 patients. Curcio said that up to 20% of those patients had a change in medical management as a result of NOVA testing.
Rather than commercializing NOVA immediately, the company is just now marketing. "We took a slower path in establishing our foundation," Curcio said. "We didn't rush out the door to establish every imaging center that we could. We established the neurosurgical arena first. We've spent a good bit of time getting thought leaders who would support NOVA and bring articles to peer-reviewed publication. In the first five months of 2008, we've had seven articles about NOVA published in peer-reviewed publications."
In addition to the neurovascular applications. VasSol's has introduced NOVA Renal, a gadolinium-free procedure, which offers a safe alternative to the standard contrast-enhanced magnetic resonance angiography (MRA) and MRI scans for patients suffering from renal disease. Contrast-enhanced renal MRA/MRI has traditionally required the injection of a gadolinium-based agent which the FDA has linked to the occurrence of a potentially life-threatening disease, nephrogenic systemic fibrosis. NOVA Renal provides a comprehensive evaluation of the renal arteries without contrast or ionizing radiation.
Although NOVA is a software program, the company provides it pre-loaded on a PC, which sits alongside the MR scanner with a simple plug-in to the scanner.
When a traditional MRA is run, the technologist can point and click to the vessel of interest and the information is available immediately.
Curcio declined to reveal the company's pricing strategy, saying it will be based on utilization. CMS reimbursement hasn't been achieved yet. "We're in the process of going through submission to get reimbursement approved," he said. "Having utilization and national interest are important components going forward."
Potential future applications are vast, including use in babies. "Our youngest patient to date was 6 weeks old," Curcio said. "Very young children can't receive contrast and their vessels are too small for angiograms. Now you have a safe, non-invasive test for them."
NOVA is applicable to blood vessels throughout the body. Future modules will target hepatic, coronary and lower extremity circulation.
Nearly 12 years since its inception as a spin-off from the UC, VasSol is on the verge of big growth but plans to keep it in house. NOVA is the company's flagship and only product, and Curcio said "We have great friends at GE and Siemens and Philips, but we've put forth every effort to keep our independence. Although we're not looking for funding today, we may do an expansion round in the future in 2008. But we're well funded right now," he said, adding that all funding has come via private equity investments and high net worth individuals.
NOVA is the brainchild of neurosurgeon Fady Charbel, MD, who understood the importance of knowing blood flow in the brain to effectively treat stroke victims.
VasSol finished ISO certification, gained CE Mark approval and just recently passed Health Canada's regulatory hurdles.