New Kid on the TAVR Block Aims to Give Edwards, Medtronic A Run for Their Money

 The TAVR or transcatheter aortic valve replacement market in the U.S. has only one established player with an approved product - Edwards Lifesciences.

The California company will have had at least a two-year head start assuming Medtronic will launch its CoreValve product in 2014. Both company's products are available in Europe where they compete with European TAVR startups as well as St. Jude Medical. Boston Scientific also has its own offering about to launch in Europe.

But significant leads by the most established names in the medical technology world hasn't prevented an upstart company based in Broomfield, Colorado, to begin testing its own transfemoral TAVR product. 

Colibri Heart Valve has finished implanting two patients with what it calls the world's "first and only dry, pre-mounted and pre-packaged low profile, 14 French, transcatheter aortic heart valve." 

And that gives them the advantage over household names in the TAVR space, said Joseph Horn, CEO of Colibri, in a recent interview.

"Right now we are the only company that has a product that is ready for an implant into a patient from the package [itself]," Horn said. "So for vascular access, we have an advantage there because we are pre-packaged dry, which takes the water out of the tissue."

Essentially what he and Eric Schauble, Colibri's VP of corporate development, mean is that currently available TAVR products are shipped separately. The valve is shipped in a sterilant such as formaldehyde and need to be rinsed thoroughly before use. The valve also need to be crimped prior to being loaded into a delivery system to get it ready for the implant procedure.

Horn said that unless the TAVR valve is rinsed properly, remnants of the sterilant the valve is stored in can cause calcification and damage the tissue. 

Contrast that to Colibri's product that is ready out of the box. 

"Centers have to have a nurse or a technician to prepare the product. With our product, they don't have to do that. The person could be doing something else or they could even have one less person in the procedure," Horn said.

An Edwards Lifesciences spokeswoman did not directly address the issue, but instructions for use documents available online indicate that the valves need to be hydrated in a sterilant and need to be rinsed before use. 

A Medtronic spokesman pushed back against the idea that healthcare providers have to bother with all this work.

"Each valve needs to be rinsed prior to implant," said Kathleen Janaasz in an email. "The valve is fully assembled by Medtronic so no assembly is required by health care providers."

No rinsing or assembly required immediately before surgery is not the only advantage that Colibri executives believe their product has.

The Colibri system is delivered through a 14-French balloon catheter, while other products on the market are delivered at minimum with a 18-French, Horn said.

"Right now we are delivering through a 14-French introducer, and for femoral access that's a huge advantage. Because we are a much smaller catheter we are going to be able to traverse through the anatomy more smoothly," Horn said.

While his statement is accurate for now, Edwards is planning to introduce a TAVR product by year's end - Sapien 3 - which will be delivered through a 14-French expandable sheath, said Sarah Huoh, Edwards' spokeswoman. 

Currently, Colibri's feasibility trial is ongoing, and eight more patients outside the U.S. are expected to be implanted with the 24 mm heart valve delivered transfemorally. 

The company is also seeking $15-$25 million in Series C funding, said Schauble and is talking to venture capitalists and large medtech firms that he declined to name. If all goes as expected, the Colibri hopes to obtain CE Mark for the TAVR system by early 2015.

Aside from no set-up, the product also has some clinical advantages related to valve design, Horn said, adding that it allows 30% to 40% more oxygenated blood to flow into the patient's body than current systems.

Yet Horn is acutely aware of touting the product's supposed benefits at such an early stage of development.

"We only have two patients and so we don't want to scream and holler about how great it is," he said. 

-- By Arundhati Parmar, Senior Editor, MD+DI
[email protected]