The FDA’s recent approval of the Abiomed artificial heart implant will benefit only a few dozen patients annually. The next-generation model, which could be on the market in 2008, would fit more (smaller) people, but not enough to make it a blockbuster. The company is hedging its bets on assistive devices that enable ailing hearts to recover or at least stay in place.
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Abiocor Heart Approval Extended
In September, the US Food and Drug Administration approved Abiomed’s US$250,000 artificial heart implant for use in severely ill patients. Noting that the stock market did not go wild over the news, New York Times reporter Barnaby Feder writes that the device is “at best, a steppingstone to the artificial heart” originally envisioned by the company’s founder, which would serve the 50,000 transplant hopefuls annually vying for 2,000 donated human hearts. The present model is too large for 50 percent of male patients and 80 percent of women, carries a high risk of blood clots, and needs to be replaced at least every two years. That whittles the market down to about 4,000 patients annually in the US, and the unlikelihood that insurers will rush to cover it may whittle it down to a few dozen. The next-generation AbioCor II , now being tested in animals, is more than 30 percent smaller and designed to last five years. It could reach the market in 2008. Meanwhile, the company makes a living on a heart-assist device and a blood-pumping unit for patients with weakened but relatively healthy hearts — a market of a million patients. The continuous glucose monitors recently approved or under current review by the US Food and Drug Administration bring diabetics one step closer to the Holy Grail of an artificial pancreas. Eventually a computer controller will be added to create a closed-loop system between trhe monitors and available insulin pumps. The whole will then amount to an artificial pancreas, controlling glucose levels by providing the right amount of insulin at the right time. This will represent “a quantum leap,” said a Juvenile Diabetes Research Foundation researcher, who expects to see the first-generation closed-loop system within five years. CVRx Inc’s Rheos system includes an implantable device to help control hypertension — high blood pressure — in patients whose condition can’t be controlled with medication. Results from ongoing small-scale, early stage clinical trials in Europe and the United States have so far been encouraging, but it will be several years before Rheos could be approved. Nevertheless, notes Susan E. Peterson in the Minneapolis Star Tribune, judging by US$60 million in venture capital funding, eventual approval is anticipated. About 25 percent of 65 million people in the US alone with high blood pressure can’t control it with drugs, and of those, about 2 million are seen as the potential market. The Rheos system electrically activates the body’s natural baroreflex sensors in the walls of the carotid arteries in the neck, which measure blood pressure and send signals to the brain to regulate blood pressure by adjusting the heart rate, opening or narrowing blood vessels, or releasing fluid from the body through the kidneys. Electrical pulses are sent from a programmable device implanted below the collarbone with leads to the two carotid arteries. Besides more effective control of blood pressure, the system has fewer side effects than medication and does not depend on patients following their medication regimen. The eventual price of the device is undetermined but likely to be somewhere between $6,000 and $35,000. Researchers at Rensselaer Polytechnic, Harvard Medical School, Albany Medical Center, and MIT are developing a virtual simulator enabling surgeons to touch, feel, and manipulate computer-generated organs and tissues with tool handles used in actual surgery. A computational tool called “point-associated finite field” (PAFF) is used to simulate solid and liquid biological tissues as well as blood flow and smoke generation during cauterization. A chip developed at Hewlett-Packard’s UK research laboratory is the size of a grain of rice yet can store half a megabyte of data, which it can send and receive wirelessly. When ready for market, in two years at the earliest, it will probably have even more memory. The Memory Spot ’s data transfer rate of at 10 megabits per second is much faster than today’s short-range radio systems such as Bluetooth and RFID (Radio Frequency ID) tags. No battery is needed because devices reading data from the chip will provide power by induction. HP said it would show the chip to standards bodies in the hi-tech industry with a view to getting it widely adopted. Once in production the devices could cost as little as one US dollar each. Possible uses include counterfeit drug prevention, hospital patient identity (and even chart storage) wristbands, and sound or video postcards. To reduce medication errors, Kaiser Permanente will soon begin offering “Rex – The Talking Prescription Bottle” to patients with vision or reading problems at 140 Northern California pharmacies and medical facilities. The bottles contain a computer-chip-enabled recording unit that stores pharmacist-recorded medication instructions such as dosage, frequency, warnings, refill guidance, and other important information. Patients access the information by pushing a button on the side of the bottle and repeat it if necessary. A number of health care and electronics companies have come together to create an organization to ensure that their various home and remote patient monitoring devices are all compatible and help them facilitate the transmission of data from the user’s home to the device. The partnership, called The Continua Health Alliance, includes companies such as Cisco Systems, GE Healthcare, Intel, Motorola, Partners HealthCare System, Philips Electronics, and Samsung. The devices under the alliance would feature a recognizable logo for consumers and providers to look for which looking for compatible home sensors and hospital information systems. A video projector the size of a sugar cube could be used to project images from mobile phones, PDAs, and laptops, according to the Fraunhofer Institute scientists who created it. It measures less about 16x9x9 mm, and contains a red/blue laser and a vibrating mirror. Green diode lasers are not yet small enough to allow the device the full range of colors. The BBC article reporting this brealthrough implies that the previous smallest laser-based video projector was the size of a matchbox. |