More and more cardiovascular assist devices are supporting heart failure patients, and those patients are being highlighted at an increasing number of media events to support the expanded use of this technology.
Last month, Dave Harvison, a Lubbock, Texas, resident, was introduced at a press conference hosted by the Texas Heart Institute and St. Luke's Episcopal Hospital (both Houston, Texas) to testify to the value of the HeartMate VE ventricular assist device made by Thoratec (Pleasanton, California). Harvison had been supported by the device since it was implanted Jan. 19 after being admitted to St. Luke's with heart failure. He was discharged just 15 days after implantation with the Heartmate device, hospital officials said.
Whether specifically intended or not, the press conference came at a pivotal time, sandwiched between the early-March positive vote by the FDA's Circulatory System Devices Panel recommending FDA clearance of the HeartMate VE and the annual scientific sessions of the American College of Cardiology (ACC; Bethesda, Maryland) in Atlanta, Georgia, later in the month.
While the FDA panel gave a recommendation for approval, panel members also raised a variety of concerns and attached several conditions for clearance, those concerns apparently the cause of a temporary slump in Thoratec's share price – to $10.60 at one point, the lowest of the year. Overall projections indicate, however, that Thoratec will win clearance for the device in the third quarter.
Besides winning Harvison's support, the HeartMate VE device received enthusiastic backing from O.H. Frazier, chief of cardiopulmonary transplantation and director of surgical research at the Texas Heart Institute and chief of transplant service at St. Luke's. Frazier has been a key figure in the development effort, and he characterized the HeartMate's success as "the goal of the research we began here 30 years ago – to develop a pump that is feasible, meaningful and useful for patients dying of heart failure, for whom a heart transplant is not available."
Frazier estimated 4 million Americans die prematurely of heart failure each year and are unlikely to receive a heart transplant because there are only about 2,000 donor hearts available. "This is the first really acceptable solution for long-term support of these patients because it allows them to leave the hospital and return to active and productive lives," Frazier said.
The premarket approval clearance sought by Thoratec would greatly expand the patient pool for the device, which received FDA clearance for bridge to transplant in 1994, to use as a "destination therapy." A California man is the longest surviving person on the device, supported by it more than 1,140 days as of the time of the press conference, according to Thoratec. The company reports more than 3,000 persons implanted with the HeartMate worldwide.
The Texas Heart Institute is involved in a variety of trials researching heart-assist devices, and Frazier also expressed optimism concerning the progress of development for the Jarvik 2000, an ancestor of the original Jarvik-7 artificial heart device, being developed by Jarvik Heart (New York). He reported the initiation of discussions with the FDA last month concerning expansion of the current clinical trial for the Jarvik to multiple centers, as well as expanding the application of that device as a destination therapy in the U.S. In Europe, the Jarvik 2000 is approved for that application and about 35 of the devices have been implanted. A UK citizen has lived longest with the Jarvik, having been supported on it now for 21 months.
Frazier and the Texas Heart Institute and St. Luke's also have been involved in the development of the AbioCor replacement heart from Abiomed (Danvers, Massachusetts) and in January held a press conference introducing the third recipient of that device in Abiomed's current clinical trial. That patient, Bobby Harrison, died in mid-February following the complications of a stroke. Frazier has worked on development of the AbioCor for 10 years.
Abbott buying Biocompatibles' stent unit
Abbott Laboratories (Abbott Park, Illinois) has entered into a definitive agreement to acquire Biocompatibles International's (Farnham, UK) cardiovascular stent business in a cash deal valued at about $235 million. The transaction is expected to be completed in 2Q02, subject to regulatory approvals and customary closing conditions. The two companies have previously been linked under a 1999 agreement for Abbott to distribute Biocompatibles' BiodivYsio coated stents in the U.S.
Biocompatibles' efforts in the drug-coated stent arena suffered a setback in early March when recruitment in the BRILLIANT II trial, a collaboration between that company and British Biotech (Oxford, UK) was suspended because six-month follow-up studies on patients enrolled in the BRILLIANT I trial indicated the Batimastat-coated BiodivYsio stent being studied did not show the benefit evident in preclinical studies.
Abbott said acquisition of the British firm's stent business enhances its portfolio of marketed products and expands its presence outside the U.S. market for polymer-coated and, in the future, drug-coated stents. Christopher Begley, Abbott senior vice president, hospital products, said the planned acquisition "strengthens Abbott's platform in the vascular business by ... augmenting our existing work to develop and commercialize innovative new products." Crispin Simon, Biocompatibles' chief executive, said, "The combination of our organizations will accelerate market growth and will ensure the continued development of effective treatments for coronary artery disease." Abbott said it anticipates a yet-to-be determined, one-time charge in 2Q02 related to the transaction, primarily for in-process research and development.
CardioNet gets $5M from Guidant
Guidant (Indianapolis, Indiana) has made a $5 million investment in CardioNet (San Diego, California), pushing itself forward into the broader monitoring arena. CardioNet's technology provides ambulatory monitoring of arrhythmias suffered by cardiac patients and the firm describes itself as "an integrated medical technologies and services company."
Including Guidant's contribution, CardioNet raised $18.5 million in the investment round. Founded in 1999, the company reported that it has raised a total of $26 million in venture financing. This past February, CardioNet received 510(k) clearance from the FDA for its core technology, the Ambulatory ECG Monitor with Arrhythmia Detection.
CardioNet says it blends external ambulatory electrocardiogram technology with wireless telecommunications to enable remote, real-time cardiac patient monitoring via the Internet. By merging cardiac monitoring, wireless and the Internet, the company says that its technology leads to early identification of patients who may be candidates for Guidant therapies. The CardioNet service model holds considerable promise to further advance patient care in a cost-effective way, Guidant said. Guidant's Advanced Patient Management initiative is an approach to continuously monitor patients with chronic heart diseases, offering physicians the ability to monitor patient heart function remotely and automatically. With the deal, Guidant will gain exclusive co-branding rights.
Guidant is not the only major cardiac company moving to integrate Internet-based information technology and telecommunication advancements with medical device technologies, and it may be attempting to play catch-up with one of its major competitors. Earlier this year, Medtronic (Minneapolis, Minnesota) acquired the Paceart division of GE Medical Systems Information Technology (Milwaukee, Wisconsin). Paceart develops database systems for pacemakers, implantable defibrillators and arrhythmia management systems. Medtronic planned to combine its CareLink Network with Paceart's expertise in cardiac follow-up systems.
CHF Solutions relocating to Minnesota
Privately held CHF Solutions, which is developing a device to treat congestive heart failure, is moving its headquarters from New York to Brooklyn Park, Minnesota, a suburb of Minneapolis. The company and 12 relocating employees are moving to a 30,000-square-foot administrative and manufacturing facility. It plans to have nearly 50 employees by year-end.
CHF is developing the System 100, a mechanical pump and filter for removing excess fluid, which can cause severe fatigue and shortness of breath. CHF Solutions has submitted a 510(k) application to the FDA and anticipates receiving U.S. marketing clearance for the product in the next few months.
John Erb, recently named chief executive officer, said, "We plan to tap the wealth of medical technology talent, experience and resources in the Minneapolis/St. Paul market as we take CHF Solutions from the development stage to a commercial enterprise with strong growth potential." Erb said the company is in the process of raising $15 million to $20 million in private financing to fund the product launch. Included among those relocating to Minneapolis are Dr. Howard Levin and Mark Gelfand, who co-founded CHF Solutions in July 1999.
Photoangioplasty can help
Pharmacyclics (Sunnyvale, California) said researchers presented preclinical and Phase I data during the American College of Cardiology annual meeting indicating the potential utility of photoangioplasty with Antrin (motexafin lutetium) Injection in helping to eliminate some of the underlying causes of atherosclerosis. Two presentations of preclinical data demonstrated that Antrin photoangioplasty caused elimination of macrophages through apoptosis (cell death). One study presented by Dr. Motoya Hayase of Stanford University (Palo Alto, California) showed that local delivery of Antrin PA caused reduction of macrophages and atheroma burden in an in vivo animal model. The other, presented by Dr. Krishnankutty Sudhir of Pharmacyclics, said Antrin PA caused apoptosis of macrophages and coronary smooth muscle cells in vitro in human coronary artery cells.
Another paper analyzed data from a Phase I study that further demonstrated the safety and feasibility of Antrin PA in coronary artery disease. Jeffrey Popma, MD, of Brigham and Women's Hospital (Boston, Massachusetts) and colleagues concluded that treatment with Antrin PA in patients undergoing stent implantation did not result in deleterious lumen changes at the edge of the treatment zone (also known as "edge effect").