CD&D s

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 Cardiovascular Devices & Drugs 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. And just last week Sadra Medical (Campbell, California), another young company, reported raising $30 million to further develop its Lotus device for PAVR.

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. 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 CD&D.

"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 CD&D 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."

Obama, industry offer health savings

The healthcare reform movement in Congress promises sweeping legislation on the Senate floor by no later than this month, but President Obama made an announcement at the White House in mid-May detailing a series of voluntary reforms that will shave 1.5% per year off the pace of healthcare inflation, assuming those changes have the desired effect.

During Monday's press conference, Obama said the participants "are here because of one indisputable fact: that we are on an unsustainable course" that is financially disruptive to families, businesses and governments. Obama also noted that "half of all personal bankruptcies stem from medical expenses." Among the participants were America's Health Insurance Plans (Washington), the American Medical Association (Chicago), and the Advanced Medical Technology Association (AdvaMed; Washington).

The proposals are said to save as much as $2 trillion over the next decade, in part by reducing hospital readmissions. The mechanism expected to trim readmissions is based on the value-based purchasing concept, which in this case would consist of bundled payments for specific care episodes. That model, however, may strike some providers as the return of capitation, a notion that grew quickly and died even more quickly in the 1990s. This is projected to save $25 billion over the decade.

Another $177 billion may be saved by imposing a competitive bidding program on providers operating under Medicare Part C, also known as Medicare Advantage. In this scenario, providers would offer bids, the average of which would be used to set reimbursement rates. This is also seen as a way to reduce physician payment under Medicare Part B, but related documents do not explain the connection. Physician fees under Part B have been the scourge of cost containment efforts, with Congress intervening every time the sustainable growth rate mechanism has suggested a cut in physician fees.

Steve Ubl, president/CEO of AdvaMed, said in a statement yesterday that the association is "very pleased to join with President Obama and our industry colleagues to advance the important goal of improving access to affordable, quality healthcare." He also stated that the meeting "and the cross-industry consensus it represents are an important step toward making comprehensive health reform a reality."

FDA budget relies heavily on user fee increase

The Obama administration has released its proposed budget for FDA for fiscal year 2010, and if the White House gets its way, the agency may have in excess of $3 billion to work with for the year starting Oct. 1. The one feature of the proposal that is sure to rankle health advocates and industry alike, however, is a growing propensity to rely on user fees to fund the agency's operations.

According to a May 7 FDA statement, the $3.2 billion request constitutes a 19% increase from the agency's funding in the current fiscal cycle, but of the roughly $410 million increase itemized in the FDA statement, only $295 million comes out of the taxpayer pocket and another $215 million would be paid in industry user fees. User fees would account for more than 40% of the increased FDA funding.

Much of the increase would fund a pair of initiatives dubbed Protecting America's Food Supply and Safer Medical Products, at approximately $259 million and $166 million, respectively. However, the numbers do not indicate that the White House expects to have to fund an FDA tobacco regime, a proposition that is drawing mixed reviews on Capitol Hill (see item below).

Acting FDA Commissioner Joshua Sharfstein, MD, said in the statement that the "historic increase in the FDA's budget is a great investment in public health."

In a May 7 statement, Stephen Ubl, president/CEO of AdvaMed, said the association "applauds the Obama Administration for providing a significant increase to FDA's medical device program budget for FY 2010," a reference to the boost to funds for the Center for Devices and Radiological Health from $280 million to $315 million. Ubl also stated that AdvaMed would urge Congress "to expeditiously approve the president's budget request."

Medtronic launches stent graft mortality study

Atherosclerosis can have deadly consequences, one of the deadliest results being the development of a thoracic aortic aneurysm (TAA), a bulging of part of the wall of the aorta, the body's largest artery.

Treatment depends on the location of the aneurysm, with the least invasive therapy (after medication) being stenting. However, to date, no studies have taken a long-term analysis of survival following stenting, a technique now only a few years in use.

Medtronic (Minneapolis) has now reported the initiation of THRIVE, the company's U.S. post-market clinical study of its Talent Thoracic Stent Graft for the endovascular repair of TAAs. With several hundred patients to be enrolled, this is likely to be the largest and longest-term study to examine the survival potential of patients who receive stents to treat these aneurysms.

"We are trying to get overall realistic outcomes data," Karthikeshwar Kasirajan, MD, the principal investigator of THRIVE, told CD&D. "We are hoping to have more than 400 patients followed for five years. It's probably the largest trial for this indication and the largest number of patients enrolled and followed for the longest period of time."

Kasirajan, who also is the leader of the team that performed the first study implant on April 20 at Emory University Hospital (Atlanta), predicts that full data won't be available from the study until 2018 because enrollment will be graduated.

Medtronic's Talent stent was approved in June 2008, with this study part of an FDA post-market requirement.

The Gore TAG Endoprosthesis System from W. L. Gore & Associates (Flagstaff, Arizona) was the first endovascular grafting system approved in the U.S. to treat TAA, in early 2005.