Keystone Heart has raised US$14 million in series B funding for cerebral protection devices. By protecting all brain territories, the TriGuard cerebral protection device is designed to minimise the risk of cerebral damage during transcatheter aortic valve implantation (TAVI) and other cardiovascular procedures.
Keystone Heart’s TriGuard, according to the company, is the only cerebral protection device specifically designed to provide full coverage to all aortic arch take-offs. By protecting all brain territories, the TriGuard cerebral protection device is designed to minimise the risk of cerebral damage during transcatheter aortic valve implantation (TAVI) and other cardiovascular procedures.
The current round of financing is expected to be dedicated to conducting a European multicentre, randomised clinical trial during TAVI procedures, as well as a planned Food and Drug Administration (FDA) investigational device exemption (IDE) study. According to the company, these studies aim to enable further assessment of the efficacy and performance of the TriGuard and are expected to generate additional clinical data to support the TriGuard commercialisation globally. Keystone Heart is planning additional studies to leverage the TriGuard product pipeline in TAVI and other cardiovascular indications.
Hank Hauser, formerly vice president clinical affairs at Vessix Vascular, has recently joined Keystone Heart as vice president clinical operations, to support these expanding clinical activities.
DEFELCT I clinical data, presented at EuroPCR 2013 (May; Paris, France), demonstrated a significant reduction of over 60% of new brain lesion volume during protected TAVI procedures using TriGuard, compared with historical data on unprotected TAVI procedures. DEFLECT III, a multicentre, randomised clinical trial, conducted in up to 12 centres across Europe and Israel, is currently enrolling patients undergoing TAVI procedures, to evaluate this critical effect further.
“When performing TAVI procedures, we should provide embolic cerebral protection to protect the brain from insult. I strongly believe that TriGuard makes a difference” says Joachim Schofer, head of Universitares Herzzentrum in Hamburg, Germany, one of the leading investigators participating in this study.
TriGuard is not commerically available in the USA.