In a nearly unanimous vote, an FDA panel voted last month to oppose new labeling sought by WorldHeart (Ottawa, Ontario) for its Novacor LVAS (left ventricular assist system) for use with very sick heart-failure patients. The panel said WorldHeart did not present enough evidence to show the device would let those sicker patients improve enough to receive a heart transplant.

Several members of the agency's Circulatory System Devices panel said they viewed the company's attempt to gain an approval for this niche indication as a "back door" effort to enter the destination therapy (DT) market by circumventing the full premarket approval (PMA) clinical trial-and-review process. The company currently has FDA approval for use of the system as a bridge to transplant, but has actively been seeking the full destination therapy indication.

The Novacor system, which WorldHeart acquired from Edwards Lifesciences (Irvine, California) in June 2000, is an implanted, electromagnetically driven pump that provides circulatory support by taking over part or all of the workload of the left ventricle. With implants in more than 1,500 patients, no deaths have been attributed to device failure, and some recipients have lived with their original pumps for as long as four years.

Currently, only Thoratec (Pleasanton, California) has a destination therapy approval in the U.S. Its Heartmate XVE was cleared via a PMA supplement in April 2003 and the original HeartMate VE device was granted the first DT clearance in November 2002.

At the panel meeting, WorldHeart officials presented data from earlier studies they said showed Novacor could help restore critical organ function necessary to meet transplantation criteria. However, the panel, which voted 10-1 against the label change, said the patients studied already were organ transplant candidates and did not represent the fringe patients who would get the device under the proposed new wording.

WorldHeart Chief Executive Officer Roderick Bryden said the company is conducting further studies to seek FDA approval for Novacor as a permanent device. But some panelists said they were concerned the company's proposal was an attempt to bypass that process. Judah Weinberger, a panel member from Columbia University (New York), said WorldHeart's request seemed like an attempt to "open the back door" to permanent use of the device. The FDA's experts suggested that the company conduct a randomized trial with patients who are not well enough to receive donor hearts, as well as provide long-term data on survival rates.

"We're obviously disappointed with your conclusions," Bryden told the panel, adding that the company was not seeking a quick route to permanent Novacor LVAS use. The agency's experts pointed out that the device was not currently prohibited from use in sicker patients and that such a decision should be left up to doctors, not regulators. "In my judgment, the current indication does in fact allow the current population to have its needs met," said panelist Clyde Yancy of the University of Texas Southwestern Medical Center (Dallas, Texas).

WorldHeart was seeking approval to implant the pump in so-called "bridge" patients who are not organ transplant candidates but are expected to need transplants. The pump has broader approval in Europe and Japan, including some non-transplant patients.

In a research report, Jason Mills, an analyst with First Albany Capital (San Francisco, California), characterized WorldHeart's expansion request as a "Bridge to Bridge." In other words, bridging patients with a heart pump in order to qualify them for a donor heart, at which time they would be eligible to be bridged with a heart pump until a donor heart is found. "Even if [WorldHeart] were to have been successful in its attempt at the panel," Mills said, "we believe Thoratec would have filed a PMA supplement to receive approval for this indication."

Mills viewed the setback as a "modest positive" for Thoratec, noting that the company's HeartMate is all but assured of a U.S. monopoly for the destination therapy market through at least 2008.

Defibtech gains a niche in AED market

When one looks at the competition that automatic external defibrillator (AED) maker Defibtech (Guilford, Connecticut) faces, it's a wonder how it manages to survive, and not only that, but thrive in a market that would appear at first blush to be completely saturated.

Company co-founder and President Gintaras Vaisnys had an answer for the firm's success in the face of such seemingly long odds. He said that the larger companies were approaching the defib market "from a big medical device company perspective. They're used to selling products into the ambulance market, hospital market and so on," he told Cardiovascular Device Update. In contrast, Vaisnys said that he and co-founder and Chief Executive Officer Glen Laub, MD, approached the market from a different angle. "We saw that the market was going to take off and really start servicing the non-traditional medical markets the first responder, the commercial market [and] eventually even the home market. That's a very different market with different needs. Given our background in doing product development not only in the medical area but also in the consumer area, we thought that we could do a better job of making something more usable and more user- and consumer-friendly."

Defibtech, which was founded in 1999, is able to thrive, Vaisnys said, because it is "structured for the new way of doing business." By that, he means that larger companies involved in the space have hundreds of sales representatives working for them, selling all their products. In contrast, he said Defibtech sells only through distribution networks because the AED market is very "shallow and wide." He noted that the market has changed to where hotels, gyms, restaurants, airlines and corporations are buying the units. "Guess what?" he said. "The Medtronic [Minneapolis, Minnesota] reps are not going into the restaurants or gyms because they've never been there before, and that's where the market is these days."

The other part of the equation for the company's success is the simple but elegant design of its AEDs. "Our unit is very simple to use; everything is on the front face," Vaisnys said. The Defibtech AED "talks" to the user, giving audible step-by-step instructions on how to give lifesaving defibrillation. The unit's bright yellow-and-black design makes it recognizable and easy to find quickly. The company also said that its device has the industry's longest operational battery life and is built to the durability standards of professional emergency personnel.

He said his firm's Lifeline AED is not only a well-made unit, but also the lowest-priced AED on the market in the U.S. at this time at about $1,495 vs. an average price of $1,995 for the competition.

Defibtech reported last month that it had gained clearance from the FDA to market pediatric defibrillation pads for the Lifeline. The pediatric pads are designed to be used on children under age 8. The pads attach to the child's chest and deliver the AED's lifesaving defibrillation at an optimal energy level. According to American Heart Association (Dallas, Texas) 2004 heart disease statistics, about 340,000 Americans lose their lives to sudden cardiac arrest (SCA) each year, and SCA accounts for 19% of sudden deaths among children age 1 to 13.

Defibtech said that this product enhancement will enable schools and community resources serving children to have pediatric pads for the best-value AED on the market. Many states have passed or introduced legislation that facilitates or mandates the placement of AEDs in schools. The pediatric pads are available as an option with the Lifeline AED at a list price of $99.

While pediatric capabilities are not a large part of the AED market, Vaisnys noted that it is important for the company to cover the whole spectrum of AED use. The company is privately funded and according to Vaisnys, debt-free, all positives in the event that it chooses to go public or seek a buyer, though he didn't indicate that either of those scenarios were in Defibtech's immediate future.

The Lifeline was approved for sale by the FDA in mid-2002 and the company began shipping product in early 2003. The device also has earned the CE mark.

Biopure has new CEO, cardio focus

Biopure (Cambridge, Massachusetts) last month reported sweeping organizational and strategic changes, including the naming of a new president and chief executive officer, restructuring of the company's management team, realignment of corporate strategies and a reduction in work force. As part of the restructuring, Biopure has reduced its staff by 25 employees. Those cuts come on the heels of a 30% reduction in staff implemented in January, an adjustment that trimmed more than 60 positions from employee rolls that at the time totaled just over 200. The troubled developer of the oxygen therapeutic Hemopure has identified as its main strategic focus the clinical development of the product for potential applications in cardiac ischemia, including ischemia associated with acute coronary syndrome.

Biopure is currently sponsoring a six-center, 45-patient Phase II clinical trial in Europe to assess the safety and feasibility of Hemopure, at low doses, as a potential cardioprotective agent in patients undergoing coronary angioplasty. The trial, which is being conducted in cardiac catheterization labs at academic hospitals in the Netherlands, Belgium and Germany, has reached 25% enrollment.

The board has appointed Zafiris Zafirelis president and chief executive officer and a director of the company. He replaces Thomas Moore, who resigned those posts in late February. Zafirelis, a former director of product applications at Biopure, returns to the company with extensive experience at the CEO level, including the past nine years in that position with companies in the fields of interventional cardiology and cardiac surgery. Zafirelis was CEO of MedQuest Products (Salt Lake City, Utah), a developer of implantable ventricular assist devices. Prior to that, he was CEO of CardiacAssist (Pittsburgh, Pennsylvania).

In keeping with its new focus in cardiology, BioPure has established a medical advisory board including authorities in the fields of cardiovascular research, interventional cardiology and cardiac care, under the chairmanship of Dr. Martin Leon, chairman of the Cardiovascular Research Foundation and director of cardiovascular research and education at Lenox Hill Hospital (both New York). Commenting on the company's new focus, Leon said, "Based on what we have seen so far, we feel that Hemopure has the potential to help reduce infarct size in patients with acute coronary syndrome."

Angiotech continues its ortho push

Angiotech Pharmaceuticals (Vancouver, British Columbia), a company best known for making coatings for coronary stents and other medical devices, continued its more recent push into the orthopedics and spinal surgery market with a pair of investments announced last month totaling roughly $38 million.

In the first deal, the company said it would be making a $25 million investment in Orthovita (Malvern, Pennsylvania), a specialty orthopedics company. The two companies also signed a sales and distribution agreement to share the North American rights to Angiotech's Costasis product and will be working together to reposition Costasis for use in spine and orthopedics surgery under the brand name Vitagel.

Vitagel is a liquid hemostat used to control bleeding and promote soft-tissue healing in surgical procedures in the spine, hip, knee and other areas. It is estimated that more than 1.6 million spine, hip and knee surgical procedures are performed annually in the U.S. Vitagel is designed for use in orthopedic, cardiovascular, urologic and general surgery procedures, and has received both CE mark and FDA approval as an adjunct to hemostasis when conventional procedures are ineffective or impractical.

Separately, Angiotech said it was fully acquiring NeuColl (Los Gatos, California), a privately held orthobiologics company, for $13 million. Early last year, Angiotech purchased Cohesion Technologies and as part of the deal inherited an equity stake in NeuColl, which makes collagen-based products for orthopedic and spinal applications.

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