Edwards Lifesciences (Irvine, California) said during its 2003 Investor Conference in early December that it plans to sell its LifePath AAA Endovascular Graft System in order to focus on its heart valve therapy devices and on catheters used to monitor heart performance during surgery. Abdominal aortic aneurysms (AAA) result from a bulging in the aorta, the major vessel that distributes blood through the body. Unlike traditional treatments, which require open chest surgery, the Lifepath system treats the aneurysm through a small incision in the leg.

Edwards said it intends to explore "strategic alternatives" for the Lifepath system. The system, with its unique balloon-expandable design, is currently sold outside the U.S. and is in clinical trials in the U.S. "The favorable clinical results we have experienced to date and the growing adoption of the device in Europe continue to support our belief that the Lifepath System can greatly benefit patients with AAA disease," said Michael Mussallem, chairman and chief executive officer. He added that despite the "encouraging results" and the clinical need for AAA products, "additional investment is necessary in order for it to attain a leading global position. By focusing our resources on fewer, high-potential initiatives, we believe we can improve their probability of success."

Edwards was forced to halt a clinical trial of the product in April 2000 after it was discovered that some of the wireforms of the graft material which covers the tubular body of the device had fractured. That discovery also resulted in withdrawal of the Lifepath system from the European market. The company received a CE mark for a relaunch of an improved version of the system in October 2001 and a clearance for a relaunch of its U.S. clinical trial that same month under an investigational device exemption.

Stuart Foster, corporate vice president, technology and discovery, added to the "additional investment" point during the webcast of the investors conference by noting that the company would still have to go though a U.S. premarket approval process with LifePath. He also said that in order to remain competitive in the market, Edwards would have to incur continued development costs, "in terms of additional sizes, in terms of adapting our graft for supra-renal use probably adding an aorto uniliac graft as well as a thoracic graft." And lastly, he said the company will need to add a clinical specialist channel into the U.S. to introduce the product. The Lifepath system so far generates an estimated $4 million a year in sales. The company said it still plans to submit its final marketing application to U.S. regulators early this year and expects to receive approval by the end of 2004.

Larry Haimovitch, president of Haimovitch Medical Technology Consultants (Mill Valley, California), who covers the cardiology sector for The BBI Newsletter and its sister publications, Cardiovascular Device Update and Medical Device Daily, expressed surprise at the decision. "To me, the AAA market still holds a lot of promise," he said. "They have [previously] touted this as an important new area for them."

During the meeting, several initiatives were outlined that the company believes will drive sales growth and profitability in 2004 and beyond. Among the "more promising" programs, Edwards highlighted initiatives in its replacement heart valves and repair products. "This year, we have introduced an unprecedented series of new products, including Perimount Magna, Tricentrix and IMR Etlogix," Mussallem said. He also said the company is taking "aggressive steps" to improve its domestic heart valve sales growth rate, which for the past two quarters has been "lower than our historical double-digit rate. An increase in sales and marketing resources, combined with our new products and an already strong offering, are expected to positively impact our growth rate in 2004."

In addition to continued development of heart valve products with even greater durability and performance than those available today, Edwards said it is investing in several new interventional platforms that it said could "substantially expand" the heart valve therapy market. The company said it is pursuing two new approaches for repairing diseased mitral valves using catheter-based systems, and also is developing a catheter system for replacing a diseased aortic valve. Mussallem also noted that the peripheral stent market represents a "significant growth opportunity." He added that the September introduction of Edwards' balloon-expandable LifeStent System represents the first in a series of new non-coronary stent offerings that the company expects to introduce over the next several months, including its flexible self-expanding stent.

Abbott names its spin-off Hospira

Abbott Laboratories (Abbott Park, Illinois) said it has come up with a name for its hospital products spin-off, plans for which were first disclosed in late August. Hospira will be the name of the new, independent global hospital products company Abbott expects to launch in the first half of this year. Employees of the new company, which will be headquartered in Lake Forest, Illinois, selected Hospira through a global voting process. "The employee selection of our new company name is an important milestone in creating the identity for what will be one of the leading global manufacturers of hospital products," said Christopher Begley, currently senior vice president, hospital products at Abbott, and due to become chief executive officer of Hospira.

Abbott said the spin-off would create one of the largest makers of hospital products in the U.S., with businesses that include medication-delivery systems, generic pharmaceuticals and contract manufacturing. The new company's operations would represent about 10% of Abbott's current net income, the company said. The spin-off is designed to allow Abbott to focus on higher-growth segments and proprietary products, it said in August. The move allows the company to divest slower-growing assets in a tax-free distribution, raise its long-term growth rate and focus its resources on its faster-growing segments, such as pharmaceuticals, vascular and orthopedics.

Abbott plans to retain its hospital operating-room drugs, proprietary hospital drugs and pain-management products, as well as portions of the international hospital business, all of which will become part of its global pharmaceuticals division. It also will retain Abbott Vascular Devices (Redwood City, California), including the Perclose, Biocompatibles and Jomed assets, and the recently acquired Spinal Concepts (Austin, Texas), which will continue to be operated through Abbott's Medical Products Group.

Hospira will have about $2.5 billion in sales and more than 14,000 employees worldwide. It will be a specialty pharmaceutical and medication delivery company, and its business will include medication delivery systems, such as medication management systems (including electronic pumps), infusion therapy and critical care products; and specialty injectable pharmaceuticals, including generic acute-care injectables and intensive care pharmaceuticals.

Angiotech, C.R. Bard terminate agreement

Angiotech Pharmaceuticals (Vancouver, British Columbia) said its license agreement with C.R. Bard (Murray Hill, New Jersey) has been terminated by mutual agreement of the two companies.

The license agreement, originally entered into in 1998, provided for the use of paclitaxel and other related compounds for the perivascular treatment of stenosis associated with peripheral vascular surgery. The parties' primary focus under the license agreement was a paclitaxel-loaded biodegradable vascular wrap for use in peripheral vascular surgery.

The paclitaxel-loaded biodegradable wrap, developed by Angiotech, is being tested in a 60-patient clinical trial in Europe and the Netherlands Antilles. Angiotech retains all rights to the program and said it intends to continue to independently develop the product.