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FDA okays systems to assist heart until transplant is available
By DON LONG
BBI News Managing Editor
Two new heart-assist devices approved by the FDA on Tuesday promise a quantum leap forward in the quality of life for persons awaiting heart transplants but, until now,forced into hospital bed confinement.
Made by Thermo Cardiosystems (Woburn, Massachusetts) and Baxter Healthcare's Novacor unit (Oakland,California), these devices maintain blood flow through the body and are highly portable, allowing the patient to leave the hospital. These are the first approved systems that make it possible for heart transplant candidates to return home, to school or work and perform other functions of normal life.
Baxter's product, the Novacor LVAS (for left ventricular assist sytem), and Thermo Cardiosystems' HeartMate Vented Electric LVAS are very similar in operation. The HeartMate is an advanced-generation version of the HeartMate device approved by the FDA in 1994 for use in
hospitals.
In another product development aimed at improving heart patients' independence, Meridian Medical Technologies (Columbia, Maryland) has launched in Israel a wallet-sized ECG device that provides greater patient freedom from the emergency room or other health facility.
The LVAS devices approved by the FDA are both essentially blood pumps implanted in the abdominal area and then connected by cable through the skin to a small external computer worn at the waist. The computer is powered by a base unit that is either plugged into the wall or run off batteries worn at the waist or, as in the HeartMate product, under the arms.
The pump is connected to the left ventricle, the main pumping chamber of the heart. From there, blood is pumped by the devices into the main artery supplying blood to the body. After recovering from the procedure of pump implantation – usually taking two to three weeks –
most patients are able to leave the hospital while awaiting a donor heart.
The systems are approved for use in patients with irreversible heart failure whose condition is deteriorating so rapidly they are likely to die in 24 to 48 hours, the FDA said in a statement. Additionally, they can receive the devices only if they are on the hospital's transplant list.
The devices don't allow total freedom of movement. Patients must stay fairly close to a hospital or heart transplant center that is able to manage the devices. And they must be trained to use the system before leaving the hospital.
Each year, about 2,000 to 2,400 hearts are available for transplant, figures far outnumbered by those needing transplants, estimated at 20,000 to as many as 40,000 a year.
The Novacor LVAS has been marketed in Europe since 1994 as both a bridge to transplant and a long-term alternative to other medical therapies, such as chronic drug treatment and heart transplantation. Baxter reports that 27 people have been supported with the devices for
more than one year, three for more than two years, and two for more than three years.
The system is "durable, reliable and easy for patients to use," according to Perr Portner, PhD, chairman of Baxter's Novacor unit and a pioneer in LVAS technology. "Our ultimate goal has always been to evolve into a totally implantable system that would serve as a long-term alternative to other medical therapies like chronic drug treatment and heart transplantation."
Robert Kormoss, MD, director of the artificial heart program and adult cardiac transplantation at the University of Pittsburgh and one of the product's principal investigators, called the Novacor device "the next best thing to a natural heart that you can pull off the shelf, put in
somebody and provide normal function to someone who's dying."
Thermo Cardiosystems began testing its HeartMate system in 1991, with clinical trials conducted at 25 transplant centers. Like the Novacor, it received European approval in 1994. The company's two versions of the device – pneumatic and electrically powered – also have received approval in Canada and selected regions of Asia.
The company's own research indicates that the HeartMate doubles the possibility of its user surviving long enough to receive a transplant.
Estimates of the potential number of people who qualify for implantation of the devices range from 15,000 to 40,000.
The current market for heart devices for survivability to transplant is somewhat more than $100 million, according to estimates, but if the FDA approves them as substitutes for transplant, that figure could explode to $2 billion to $4 billion.
Though not as sophisticated as the heart-assist devices, the CardioPocket ECG device just rolled out in Israel by Meridian Medical also allows the user greater independence from hospital or emergency room facilities. Small enough to be carried in a wallet or pocketbook, the device allows at-risk heart patients to monitor their
condition while carrying out regular activities.
The CardioPocket is used "when patients experience cardiac-related symptoms," according to Jamil LaHam, general manager of Meridian's Cardiopulmonary Systems group. "They can simply place the CardioPocket against the chest and, using any telephone or cellular phone, transmit within seconds a real-time ECG strip to a health center for immediate consultation."
The device recently received the CE Mark in Europe, and Meridian is preparing a 510(k) submission to the FDA. Since rollout in Israel, the company initially predicts annual sales of 10,000 units. Under terms of an alliance, the device is being marketed worldwide by Shahal (Tel Aviv, Israel).
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