CardiAQ Valve Technologies (CVT; Winchester, Massachusetts) – a company that hopes to do for percutaneous mitral valve replacement (PMVR) what companies like CoreValve (Irvine, California) have done for percutaneous aortic valve replacement (PAVR) – has received $750,000 in seed money from Broadview Ventures, a spinoff of Fondation Leducq (Paris).
"This sector is filled with significant opportunity," said Brent Ratz, president/CEO of CVT. "CoreValve and others have demonstrated already how catheter-based heart valve replacement technology can address aortic stenosis. We believe that our platform has the unique capability to do the same thing for mitral regurgitation, and we are pleased to have Broadview's support as we continue to move this exciting technology forward."
CVT said the funding, which brings its total funding to $1.5 million, will be used to further develop the company's platform with an initial indication for PMVR. While the company is focusing on PMVR first, Ratz told Medical Device Daily that CVT does plan to eventually go beyond the mitral side to treat other parts of the heart, including the aortic side.
A lot of hype has been made lately about PAVR – most likely due to Medtronic's (Minneapolis) recent $700 million purchase of CoreValve, completed in April (Medical Device Daily, April 13, 2009). And just last week Sadra Medical (Campbell, California), another young company, reported raising $30 million to further develop its Lotus device for PAVR (MDD, May 8, 2009).
Edwards Lifesciences (Irvine, California) currently controls the lion's share of the PAVR market but Medtronic and St. Jude Medical (St. Paul, Minnesota) are posturing to capture some of the market share as well (MDD, Feb. 24, 2009). Edwards' Sapien transcatheter heart valve received the CE mark in 2007. That year the company also initiated its PARTNER trial in the U.S. to evaluate the Sapien valve in patients who are considered high risk or inoperable for conventional open-heart surgery. CoreValve received the CE mark for its ReValving PAVR system in May 2007.
But there hasn't been as much chatter about PMVR – until now.
According to CVT, when the mitral valve fails to close completely, blood flows back into the left atrium. The heart must then work harder to pump blood to the rest of the body, which weakens the heart and may eventually lead to heart failure. CVT's solution, PMVR, is to insert a catheter carrying the replacement valve threaded through the femoral vein up into the right atrium of the heart. It is passed through the intra-atrial septum, into the left atrium, and down through the mitral annulus. The valve is partially expanded to engage the ventricular side of the annulus and establish the proper position. While the valve is now functional, it can be recaptured and adjusted prior to final deployment, if necessary. With the valve in position, the sheath is retracted fully. Foreshortening of the frame creates a clamping action that anchors the valve above and below the native valve annulus.
"The real difference in the technology compared to anything else out there on the replacement side is that we don't rely on radial force" for fixation in heavily calcified leaflets, which is not suitable for the mitral valve position, Ratz said.
With CVT's technology, the new mitral valve actually clamps on above and below the native valve annulus by way of a clamping motion created by foreshortening of the frame, Ratz explained. He said there is some level of radial force involved to help prevent leaking, but the technology does not rely on that as the sole means of attachment.
CVT noted that several companies are attempting to develop percutaneous approaches to repair the mitral valve, but these technologies have limited applicability due to the heterogeneous nature of the disease and, so far, have had difficulty demonstrating efficacy equivalent to surgical approaches.
Ratz said that there is a large unmet clinical need for people suffering from mitral regurgitation (MR) because about 19 out of 20 patients diagnosed with MR go untreated, primarily because their disease has already progressed to a point that it would be far too risky to think about undergoing an open surgical procedure. "There are so many patients that need a faster, safer, less invasive technology," he told MDD.
"No other heart valve company has a frame that is self-positioning, self-anchoring, and self-conforming in three dimensions. Consequently, CVT's technology has the unique potential to treat aortic stenosis, aortic regurgitation, and mitral regurgitation," said Joseph Bavaria, MD, vice chief of cardiothoracic surgery at the Hospital of the University of Pennsylvania and professor of surgery at the University of Pennsylvania (Philadelphia).
As a member of St. Jude's structural heart advisory board and a principal investigator for Edwards' PARTNER trial, Bavaria is well-versed in the new technologies being pursued within the heart valve space, according to CVT. "In vivo feasibility studies strongly suggest that CVT's PMVR approach may provide effective treatment of MR," said Bavaria, who is also chairman of CVT's scientific advisory board.
Ratz said CVT has received "great feedback" about its technology, including from the clinical side. He said that is particularly reassuring considering those folks see just about every transcatheter heart valve repair or replacement device come across their desk and they "still identify this as a novel technology."
While it's still early in the development process, Ratz told MDD that CVT hopes to be in a first in man trial by early 2011, which puts the company in position for a CE mark by 2013, and hopefully on the U.S. market by sometime in 2015. "It will no doubt be a long project and a capital intensive project, but we feel good about the fact that others are in this space on aortic side."
He added that hopefully by the time CVT applies for FDA approval, those companies with PAVR technologies would have already addressed some of the regulatory hurdles for valve replacement procedures. The $750,000 seed funding is an important step toward accomplishing those development goals.
"The move from basic science to clinical evaluation is especially difficult and expensive," said David Tancredi, MD, PhD, scientific director of Fondation Leducq. "Because funding at the early stage of a med-tech company's evolution is particularly difficult to obtain, promising new technology may simply be abandoned. In CVT's case, our goal is to prevent that from happening."