A new medical technology company--this time in France--has announced
it is joining the sparse ranks of innovators hoping to develop the
first total artificial heart to be used as a permanent implant, not
just as a "bridge" to heart transplantation. Carmat SAS made news
headlines in Europe earlier this week when it announced that it had
landed £á7M in start-up funding, plus £á33M in grants-in-aid and loans
from the French innovation and funding agency, OSEO--the largest
amount ever awarded by the agency to a start-up company.
But in addition to dollars, Carmat may already have a leg-up on
competing companies because of the star physician at the helm:
renowned cardiac surgeon and inventor Dr Alain Carpentier (Pierre &
Marie Curie University, Paris, France). In interviews with the
press, Carpentier has said that the Carmat device is based on 15
years of research, and he predicted it could be used for the first
time in humans within two and a half years.
According to a press release issued by the capital group behind the
Carmat venture, the Carmat artificial heart has already been used in
animals and undergone strenuous bench testing. The device itself
combines animal tissue, titanium, and technology borrowed from the
missile-defense industry; in fact, the European Aeronautic Defense
and Space Company (EADS) is one of the other funders of the project.
A unique feature of the design is the sensor technology used in
guided missiles, which senses the body's activity level and adjusts
accordingly.
The Heart Hunt
A total artificial heart is the holy grail of cardiovascular
medicine, with development efforts dating back more than half a
century. The most recent FDA-approved addition to the field is the
AbioCor fully implantable total artificial heart, made by Abiomed,
which was cleared in 2006 for end-stage heart failure patients who
are not eligible for a heart transplant. It has an internal battery
that lasts for just 30 minutes and a wearable external battery pack
that lasts four hours. Patients treated with the AbioCor heart have
lived on average about five months but, because of its size, only a
minority of patients can even accommodate the device. The company
has developed a smaller version, the AbioCor II, that it hopes to
get approved in the near future.
Another FDA-approved device, the CardioWest, is the modern-day
descendent of the Jarvik 7, the total artificial heart developed by
Dr Robert Jarvik in the early 1980s. The CardioWest is now
manufactured by SynCardia Systems and can only be used in end-stage
heart failure patients, in hospital, as a bridge to transplantation.
The FDA granted marketing clearance to the CardioWest heart in 2004.
Disappointing results or, more often, lack of funding has deterred
other groups and companies trying to develop a total artificial
heart. Even Jarvik Heart, the company founded by an artificial-heart
pioneer, focuses solely on the development of left ventricular
assist devices--a decidedly more crowded field of research--rather
than total artificial hearts.
Groups in Korea and Japan are reputedly working on total artificial
hearts, but any efforts in the US are either being done in secret or
seem to be withering on the vine. Innovators at the Cleveland Clinic
have been involved for years in the development of a device dubbed
the "MagScrew" total artificial heart. A Clinic spokesperson told
heartwire that, although one of the MagScrew prototypes has
been "cranking away" on a bench endurance test for two and a half
years, developers have not managed to drum up corporate funding to
do the necessary preclinical studies, despite publishing a steady
trickle of papers on the invention. According to the Clinic
spokesperson, the MagScrew is actually smaller and lighter than the
Carmat device, and requires no anticoagulation.