Volcano Corporation (NSDQ:VOLC) posted positive early findings for its instant wave-Free Ratio (iFR) coronary lesion detector, with results form its Advise II trial supporting results from older retrospective publications, according to a report unveiled during a hot line late-breaking clinical trial session at the EuroPCR meeting in Paris, France.
The company reported at EuroPCR that 392 live cases have been diagnoses in cath labs equipped with iFR software, with the iFR algorithm analyzed for the 1st time by an independent physiology core lab called Cardialysis in Rotterdam, Netherlands.
The new results continue to demonstrate that Volcano’s lesion assessment system is effective at diagnosing patients and reducing the use of hyperemic drugs. The company touts its iFR software as a pharmaceutical-free alternative to the gold standard fractional flow reserve (FFR) method for assessing narrowed blood vessels.
"These preliminary results show that the prior observations can be replicated prospectively, and that a Hybrid iFR/FFR approach can provide a greater than 90% agreement with FFR while saving the use of hyperemic agent in more than half of patients," Javier Escaned, cardiologist at Hospital Clínico San Carlos in Madrid, Spain, said in prepared remarks.
The Hybrid iFR/FFR system is slated to be evaulated in the multi-center SYNTAX2 trial starting in Europe later this year, Volcano reported.
VOLC shares were up 0.8% to $16.81 as of about 12:05 p.m. today.