Medical Device Link.

Crawford: Stepping aside.

FDA Commissioner Lester M. Crawford, DVM, PhD, resigned his post suddenly on September 23, only two months after his final confirmation as permanent head of the agency. In his place, President Bush named Andrew C. von Eschenbach, MD, director of the National Cancer Institute, as acting FDA commissioner.

"At some level, it’s obviously disappointing to lose stable leadership in the commissioner’s office,” says Stephen J. Ubl, president and CEO of industry association AdvaMed (Washington, DC). “But we’re optimistic about the nomination of Dr. von Eschenbach."

Von Eschenbach, a nationally recognized urologic surgeon who is himself a cancer survivor, accepted his appointment to lead the NCI in January 2002. Prior to that, he served as executive vice president and chief academic officer of the University of Texas MD Anderson Cancer Center (Houston). At MD Anderson, he also served as vice president for academic affairs and held the clinical research distinguished chair in urologic oncology. [ More ]

In the days and weeks following Hurricane Katrina’s rampage across the Gulf Coast, the medtech industry mobilized to supply the affected regions with much-needed supplies, ranging from bedpans and bandages to home dialysis equipment and automated external defibrillators.

But despite widespread efforts and sizable donations on the part of many manufacturers,

no single coordinating force emerged at the federal level to link available medical supplies and services to areas of specific need. Medtech manufacturers eager to help pursued a variety of means, including coordinating with U.S. Department of Health and Human Services (HHS) and other government agencies, working through industry associations to identify areas of need and courses of action, contacting affected patients directly, and contributing donations and information through a variety of nonprofit entities. [ More ]

Just about as reliably as the swallows return to Capistrano, every year the U.S. House of Representatives passes medical liability reform legislation only to see it wither on the vine over in the Senate.

This year’s incarnation of medical liability reform legislation, known as the Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2005 (H.R.5), was introduced in the House by Representative Phil Gingrey (R–GA) on July 21. The key reform provision of the bill is the capping of noneconomic or "pain and suffering" and punitive damages at $250,000. Economic damages such as medical expenses, lost wages, and other actual costs would not be capped. Authors of the bill claim that it is the increase in noneconomic damages awarded to plaintiffs that has led to the "skyrocketing rise" in healthcare costs and what they refer to as the "medical liability crisis."

The legislation also offers protection to prevent medtech manufacturers from becoming targeted by plaintiffs as the only deep pockets in sight. The bill specifically states that "no punitive damages may be awarded against the manufacturer or distributor of a medical product, or a supplier of any component or raw material of such medical product" when the product has been approved, cleared, or licensed by FDA, unless the agency has determined that it was not manufactured or distributed in compliance with applicable statutes and regulations.

On July 28, the Republican-controlled House passed the legislation with a vote of 230–194 that was split largely along party lines. The bill was then sent on to the Senate, where several variants of medical liability reform are undergoing legislative review. [ More ]

FDA’s Gottlieb: Addressing the challenge.

While recalls of implantable defibrillators and pacemakers continue to make headlines nationwide, a new FDA report explores the likely causes and incidence of device failure, as well as ways to improve device monitoring and public communications.

The FDA study covered the period from 1990 to 2002, during which 2.25 million pacemakers and 416,000 ICDs were implanted in U.S. patients. During this period, 8834 pacemakers and 8489 ICDs were removed from patients due to malfunction, making the ICD malfunction replacement rate significantly higher than that of pacemakers.

"Pacemakers and ICDs have saved many lives and the benefits of the devices clearly outweigh the risks," said Scott Gottlieb, MD, FDA deputy commissioner for scientific and medical affairs. "Our challenge remains to uncover these risks, measure them, and make information available to patients and doctors to help guide their personalized decisions about where the benefits of technologies like these outweigh known or potential risks from their use." [ More ]

FoxHollow Technologies (Redwood City, CA) and Merck & Co. Inc. (Whitehouse Station, NJ) have entered into what the companies report is the first pharmaceutical-medical device partnership focused on identifying cardiovascular disease biomarkers. Under the agreement, FoxHollow is providing Merck with exclusive access to atherosclerotic plaque samples collected from cardiovascular-disease patients treated with FoxHollow’s SilverHawk plaque excision system.

FoxHollow will receive an initial $9 million cash payment from Merck for the first year of research collaboration, which could be extended for an additional two years. If Merck elects to continue the agreement after the first year, FoxHollow will receive additional payments of at least $7 million and up to $31 million over the following two years. FoxHollow would also receive milestone payments and royalties upon achievement of the collaboration’s objectives, including the development of a pharmaceutical by Merck. [ More ]

More than six months after signing a definitive merger agreement, Cardiac Science Inc. (Irvine, CA) and Quinton Cardiology Systems Inc. (Bothell, WA) in early September completed the transaction to form Cardiac Science Corp. Cardiac Science manufactures automated external defibrillators (AEDs), and Quinton produces cardiovascular monitoring equipment.

Based on 2005 figures for both companies, the combined corporation anticipates annual revenues of about $160 million. Officials say they expect double-digit growth in 2006 and beyond.

Former Cardiac Science chairman and CEO Raymond W. Cohen, who remains with the new company as chairman of the board, said prior to the merger’s completion that he expects the added bulk of the combined company will help Cardiac Science counter its larger competitors, who, he said, "point to our size and financial position as a reason not to do business with Cardiac Science." [ More ]

Masimo’s Kiani:
Protecting innovation.

The ruling calls for a permanent injunction against all Nellcor products that infringe upon Masimo’s patents. In addition, the judgment includes an award of more than $164 million for Masimo.

"Masimo made a significant contribution to patient care and safety with its innovations," said Joe E. Kiani, founder and CEO of Masimo. "If others were permitted to profit from such breakthroughs and inventions, future innovation and ultimately patient care would suffer. We are very happy that the appellate court has issued this important decision." [ More ]

Alphatec Spine Inc. (Carlsbad, CA) in mid September acquired all the assets of Cortek Inc. (Dedham, MA), a manufacturer of allografts and synthetic products for spinal interbody fusion. Alphatec, owned by private equity firm HealthpointCapital LLC (New York City), produces spinal implants. According to Alphatec, spinal machined allografts represent a $338 million subsegment of the $3.1 billion spine products market.

"Cortek’s allograft products have long been recognized for their ability to accelerate and improve lumbar and cervical repair," said John H. Foster, chairman and CEO

of Alphatec. "The addition of these products to Alphatec’s product lineup gives surgeons a one-stop shop for improving spinal fusion patient outcomes." [ More ]

Abbott Vascular Devices (Redwood City, CA) received FDA approval earlier this month for its Xact carotid stent and Emboshield embolic protection system. The device is intended to treat carotid artery disease, which results in an estimated 700,000 strokes and 280,000 deaths in the United States annually. Carotid stents are a less-invasive alternative to the surgical procedure known as carotid endarterectomy.

Abbott’s Hance: Gaining momentum.

Robert B. Hance, president of Abbott Vascular, a division of Abbott (Abbott Park, IL), hailed the launch of the carotid stent system as "further evidence of the innovative line of vascular products Abbott has built that is gaining momentum in the interventional community." He added, "We are delighted to see the benefits of clinical and scientific advancement at Abbott result in an important new treatment for patients at risk of stroke."

It’s becoming a crowded market, but industry analysts estimate that sales of carotid stents will reach $100 million in 2006—and will likely generate annual revenue of $1 billion before the end of the decade. [ More ]

Boston Scientific Corp. (Natick, MA) announced that its Liberté drug-eluting coronary stent—described as the company's next-generation Taxus—has been approved for sale in Europe and other international locations where the CE Mark is the regulatory standard. Liberté features thin struts for greater flexibility and deliverability, particularly in hard-to-reach arteries and other challenging anatomies.

Lawrence Best, Boston Scientific’s executive vice president and CFO, said the company expects Liberté to "maintain and expand our market share." While Boston Scientific’s Taxus drug-eluting coronary stent remains the worldwide market leader, it has lost ground to the Cypher stent from Cordis Corp. (Miami Lakes, FL), a Johnson & Johnson company. In the United States, its market share has declined from more than 70% shortly after introduction in March 2004 to around 59% today. The situation is even tighter in Europe, now that Medtronic Corp. (Minneapolis) has also received approval to market its drug-eluting coronary stent, Endeavor. [ More ]

In what is likely to be one of this decade’s most closely watched trials in the medtech industry, Utah Medical Products Inc. (UTMD; Midville, UT) and FDA will meet

UTMD’s Cornwell: Facts and law.

in the U.S. District Court in Salt Lake City at the end of this month to settle a long-standing dispute over the company’s compliance with the agency’s quality system regulation (QSR).

"We remain disappointed with the length of time required to resolve this unnecessary lawsuit against UTMD and its employees, but are pleased that the time has arrived for the FDA allegations to be proven in court, on the basis of the facts and the law," says Kevin Cornwell, UTMD’s president and CEO. [ More ]

Boston Scientific Corp. (Natick, MA) earlier this month agreed to pay $750 million to Medinol Ltd. (Tel Aviv, Israel) in order to resolve a long-standing dispute over the manufacture and sale of coronary stents. Under the terms of the out-of-court settlement, the two companies also terminated all agreements and existing claims against one another in both Europe and Israel, particularly with respect to Boston Scientific’s Express and Taxus stents.

Additionally, Boston Scientific agreed to return its 22% stake in the Israeli medtech manufacturer. For its part, Medinol stipulated that any future dispute involving alleged patent infringement by Boston Scientific would be settled through an established arbitration process and that any relief would be limited to reasonable royalties. Medinol also agreed not to seek an injunction against the sale of Express or Taxus stents. [ More ]

Following a two-week FDA inspection of its cardiac rhythm management manufacturing facility in St. Paul, MN, Guidant Corp. (Indianapolis) advised physicians and patients of two types of failures that have occurred in its Insignia and Nexus pacemaker models. The failures, although statistically rare, involved the sudden and intermittent or permanent loss of pacing ability, which resulted in serious heart-rhythm disturbances.

According to Fred McCoy, president of Guidant’s cardiac rhythm management division, the failures were noted in the company’s annual reports to FDA. He indicated that determining what risk threshold to use in disclosing problems remains a troublesome issue. Noting that the current failure rates were less than three-quarters of 1% in the first instance and less than one-half of 1% in the other, McCoy said, "One of the problems that any company in high-tech medical technology deals with is the low likelihood of failure. The decision about when to communicate actively is something we all struggle with." [ More ]