CD&D Washington Editor

Medtronic (Minneapolis) in late December won a dismissal of a series of lawsuits dealing with its Sprint Fidelis lead, a legal decision in keeping with the Supreme Court ruling in February 2008 in the case of Riegel v. Medtronic, which confirmed FDA's regulatory pre-emption of state liability laws for devices having FDA premarket application (PMA) approval.

The decision is sure to light a fire among federal legislators perhaps wanting to present themselves as fighting for constituents, including Rep. Frank Pallone (D-New Jersey), who authored a bill last year that would rescind pre-emption.

The Fidelis lead was reportedly used in 90% of patients getting Medtronic's electrophysiology devices in 2007, earning the firm $1 billion before the problems began to surface. A variety of patient adverse events were reported as a result of lead fractures, including at least six deaths. In their development, to test durability, the leads were not proofed via clinical trial, but by bench testing.

The subsequent lawsuits vs. Medtronic, filed on behalf of 850 patients, ended up in the U.S. District Court for the District of Minnesota. The judge in the Minnesota district case, Richard Kyle, stated in his opinion that "at least some plaintiffs have suffered injuries from using Sprint Fidelis leads, and the Court is not unsympathetic to their plight." However, he concluded that federal pre-emption held sway in the case - meaning that PMA approval trumps any state action against the company - and that reversal of federal pre-emption "lies with Congress," in terms of new legislation.

Following dismissal, the cases are said to be heading for appeal, according to attorney Hunter Shkolnik of Rheingold, Shkolnik & McCartney (New York). Any such appeal would be handled by the Eighth Circuit Court of Appeals.

Bill Hawkins, chairman/CEO of Medtronic, said in a statement posted at the firm's web site that the company is "pleased with the Court's decision, which is consistent with the United States Supreme Court's ruling in Riegel v. Medtronic last year," and that the ruling "supports the principle that [FDA] is the appropriate body to determine the safety and efficacy of innovative technologies."

Wanda Moebius, a spokeswoman for the Advanced Medical Technology Association (Washington), told Cardiovascular Devices & Drugs in an e-mail exchange that "from a policy perspective we believe it is critical that the courts recognize FDA's long-established preemptive authority with respect to PMA products as the U.S. Supreme Court did last year." Moebius stated further than "a central, expert authority to weigh the risk-benefits of medical technologies for all Americans is key to patient access to life-saving treatments and continued innovation."

WorldHeart files IDE for Levacor

WorldHeart (Oakland, California) had a string of financial difficulties last year, but that hasn't stopped the company from moving forward with the development of its Levacor Ventricular Assist Device (VAD), intended for bridge-to-transplant (BTT) use in cardiac transplant candidates with presumed non-reversible left ventricular failure.

The company said in early January that it had submitted an Investigational Device Exemption application to the FDA for a pivotal BTT study of the Levacor VAD. The proposed primary endpoints of the study include survival to heart transplantation, explant for myocardial recovery, or survival to 180 days supported by the device.

According to the company, the IDE application includes detailed device information, including design and in vitro and in vivo pre-clinical testing protocols and results. The submission also includes an investigational plan and extensive study-related materials, WorldHeart noted.

"This IDE submission marks an important milestone for WorldHeart," said Jal Jassawalla, president/CEO of WorldHeart. "We look forward to the FDA's initial review of this submission and will answer, in supplemental submissions, any agency questions or requests. We are eager to progress to the clinical study stage in collaboration with many key clinicians in this field who have expressed a strong interest in participating."

WorldHeart says that the Levacor VAD, a fourth-generation rotary VAD, is a bearingless, magnetically levitated implantable centrifugal rotary pump. In contrast to second- and third-generation pumps with blood-immersed mechanical or hydrodynamic bearings, the Levacor uses full magnetic levitation to suspend the spinning rotor, in order to eliminate wear within the pump and allowing greater clearances around the rotor for blood flow, WorldHeart said.

Last year WorldHeart learned that its potential primary investor from an equity financing would not be able to meet its commitments. As a result, the company was not able to pay back a secured convertible promissory note in the amount of $5 million issued in December 2007 to Abiomed (Danvers, Massachusetts).

Abiomed later agreed to convert the $5 million debt to 86 million shares and, as a result, now owns a 21.6% stake in WorldHeart.

Then, in late August 2008, WorldHeart reported that it would embark on a phased consolidation into a primary facility at its Salt Lake City facility. The company said at the time its focus is on the development, clinical trial, and subsequent commercialization of the Levacor VAD.

The company first eliminated five positions, including the VP of manufacturing at its Oakland facility, held by John Vajda. It said a second consolidation phase would include the elimination of 10 additional Oakland positions and the relocation of other positions to Salt Lake City.

The consolidation plans also include a search for a CEO to reside in Salt Lake while Jassawalla stays in California in a senior management position.

In December 2007, when Abiomed agreed to loan WorldHeart the $5 million secured debt, the companies also entered into a two-year marketing and clinical support services agreement to seek opportunities to leverage existing expertise and resources of Abiomed and potentially provide it significant cost savings.

The companies said they planned to explore "technical synergies," such as the potential to use Abiomed's information and transcutaneous energy transfer (iTET) system with WorldHeart's Levacor product. Abiomed's iTET system consists of internal and external coils that are used to transmit power and information across the skin.

Daschle urged to keep it bipartisan

Room 430 in the Dirksen Senate Office Building in Washington was packed in late 2008 as the Senate Heath, Education, Labor and Pensions (HELP) Committee took up the nomination of former Sen. Tom Daschle for the post of U.S. Secretary of Health and Human Services. While the welcome wagon rolled generously for Daschle, the committee's Republican members sounded a cautionary note about any attempts to approach healthcare reform in any manner that suggests sharp-elbowed partisanship.

Among the witnesses who appeared in support of Daschle's nomination was Bob Dole, the former Republican senator from Kansas who served as the GOP leader following the 1994 elections.

Dole said, "I served with Tom for 10 years, including two years when we both served as our parties' leaders." He said he could testify "not only to his expertise on the issues," but also to his "integrity and fairness. President-elect Barack Obama, he said, had selected "an individual who will begin the task of reforming healthcare with the ability to hit the ground running," and mentioned "the fact that he understands Congress" from both ends, thanks to Daschle's service in both the House and the Senate.

"With a solid Democratic majority, you may not need Republicans," to pass a healthcare reform bill, Dole said, but he urged the committee to move in a bipartisan fashion.

Sen. Mike Enzi (R-Wyoming), the ranking Republican member of the HELP committee, offered a cautionary note on the topic of healthcare reform. He said he hopes for an emphasis in the 111th Congress "on legislation on what we can agree on, not on what divides us." Enzi said that draft legislation sometimes consists of "80% what we can agree on [and] 20% on what we can discuss forever."

Enzi said "there are going to be areas on which we disagree," but said that Congress could ensure success if it worked to "meet the 80% rule and do it through the committee process" in a way that seeks "solutions, not just debate." He also reiterated a "shared commitment to insuring uninsured Americans and containing costs."

Daschle echoed the need for bipartisanship, stating that "any effort at reform will require collaboration." Daschle said that the process of reforming healthcare "also needs to be an open, transparent process" that will give the public a close look at which reforms are put into play.

Better technology for the aging

Just as the numbers of the U.S.'s aging population have grown substantially in the past few years, so too has the number technologies and devices developed for this population group.

A new interactive study, by the Center for Aging Services Technology (CAST; Washington) shines a considerable light on the of technologies that exist and are under development to meet the needs of aging consumers and highlights what companies are doing to serve this growing market segment.

This version, which can be found online at www.agingtech.org, builds on the March 2008 publication, "The State of Technology in Aging Services," and includes links to the numerous corporations, universities and aging-services providers who are advancing technologies that can help older people stay healthy and independent longer.

"The report is comprised of research we conducted last year," Majd Alwan, PHD, director of CAST, told CD&D. "Older consumers are becoming increasingly more interested in technology and small and large corporations are working to meet this demand. Our study shows that we can create a network of technology-driven services to help people stay at home and achieve better outcomes at the same time."

The report offers a vision for long-term care that includes using integrated information technology systems to support and enhance the health, safety and social connectedness of older people living in their own homes. The authors of the report, include Alwan and Jeremy Nobel, MD, of the Harvard School of Public Health, identify several barriers to achieving this vision, but are confident that a combination of new knowledge, linked to effective collaboration among a variety of stakeholders, can overcome these obstacles to widespread technology adoption, so that older people will receive the support they need to lead healthy and independent lives.

But a lack of awareness and usability challenges, both perceived and real, on the part of older consumers tops a list of barriers that stand in the way of information management related technology adoption in aging services.

The report says that "equally troubling is a lack of consensus regarding the value of technology for some of the aging population; the absence of adequate financial and other incentives to encourage investment in this technology, and critical gaps in connectivity and interoperability among existing technologies and information systems."

The report also clearly states that more "robust studies are needed to quantify the value of these technologies, and payers and other financial intermediaries must consider adopting incentive-rich financing models to pay for technology-based solutions and encourage their widespread and effective use."

Finally, technology providers must work together and with other stakeholders to create successful business models for development and deployment of "aging in place" technologies that enhance the health and independence of older consumers.

Abandoning ICD lead said safe

New research reveals that abandoning a nonfunctioning lead in an ICD patient is safe and does not pose a clinically significant risk of complication.

The new study, published in the January edition of the HeartRhythm Journal, the official journal of the Heart Rhythm Society, suggests that the practice of abandoning nonfunctioning leads does not result in additional risk to the patient and lead extraction should be reserved for cases of system infection or when large numbers of leads have been abandoned.

Led by Paul Friedman, MD, of the division of cardiovascular diseases at the Mayo Clinic (Rochester, Minnesota), in collaboration with Michael Glikson, MD, of Sheba Medical Center and Tel Aviv University in Israel, the study was designed to examine the outcomes of lead abandonment and whether or not abandoning the lead posed significant risk.

Patients for the study were identified by retrospective review of the Mayo Clinic ICD database; data between August 1993 and May 2002 was reviewed. Patient medical records were reviewed to see whether with long-term follow-up abandoned intravenous leads increased the risk of venous thromboembolic events (vein clotting), device sensing malfunction, inappropriate shocks, and elevated defibrillation threshold values.

The rate of appropriate and inappropriate therapies and defibrillation thresholds were compared before and after lead abandonment. Previously, there had been concern that abandoned leads might interfere with defibrillator function.

"Knowing how to best handle nonfunctioning leads is important, since the number of ICD recipients is large and growing, and the component most likely to fail is the lead," said Friedman. "Because removing nonfunctioning leads includes a small risk of tearing great vessels, injuring heart valves, and death, we sought to determine whether abandoning leads is safe. For most patients, it is."

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