Colibri Heart Valve LLC

Article preview from Start-Up - July, 2013

 Colibri Heart Valve LLC has developed a pre-packaged and sterilized aortic heart valve that it thinks will further propel the transcatheter aortic heart valve implantation (TAVI) market. Its ready-for-use device has a profile that is roughly 20% to 40% less than the current market leaders, so patients with smaller femoral arteries who are currently excluded can benefit from TAVI.

Colibri Heart Valve LLC

Article preview from Start-Up - July, 2013

Coronary stenting exploded on the scene in the early 1990s, when the stent finally became pre-mounted on the balloon catheter for surgeon convenience and reduced prep time. Now, 20 years later, Colibri Heart Valve LLC has developed a pre-packaged and sterilized aortic heart valve that it thinks will further propel the less invasive transcatheter aortic heart valve implantation (TAVI) market.

“It is truly exciting that we have a product ready for use in the cath lab, as opposed to currently available TAVI systems that can have inconsistencies and error when mounting the replacement heart valve on the delivery system,” says Colibri president and CEO Joseph Horn. “Today, when valves are shipped to the hospital, they are shipped separate from the delivery catheter. It takes about 30 minutes to rinse and remove the toxic sterilant from the replacement heart valve, as well as mount and crimp [compress] the valve onto the delivery catheter, prior to use.”

Horn asserts that Colibri is the only company with an aortic heart valve that is ready for use. In addition, because the device is pre-packaged and dry-mounted, “it has a profile that is roughly 20% to 40% less than the current market leaders, so patients with smaller femoral arteries who are currently excluded can benefit from TAVI,” he says. In the US study that Edwards Lifesciences Corp. conducted on its Sapien TAVI product, which was approved in late 2011, “more than 15% of study patients could not be implanted with Sapien because their femoral artery was too large,” Horn notes. “Many of those omitted patients due to small femoral access would have qualified to use our product.”

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