The Neurotechnology Industry Association has launched an effort to get the National Neurotechnology Initiative Act passed. It would devote $1 billion to accelerate development of products to treat brain-related illnesses, injuries, and diseases. The group wants to lock up Congressional support as quickly as possible and get hearings on the bill held before the August recess. It is encouraging its members and other stakeholders to write their representatives in Congress to let them know of the bill’s importance. On its Web site, it has included draft letters and instructions for personalizing them and sending them.
Two monkeys with sensors implanted in their brains have been able to control a mechanical arm with their thoughts, a paper published in the journal Nature revealed. That leads to the question of whether we might be able to provide brain-controlled prosthetics to paralyzed humans, the New York Times reports. The experiment picks up where previous studies left off. Those demonstrated that people could control a cursor on a computer screen with their brain waves, and that monkeys with the sensors could move mechanical arms and legs. But this one is the first to demonstrate that precise control of the prosthetic is possible. The next step is developing a workable wireless system that wouldn’t need connections through the scalp.
ECRI Institute, a nonprofit organization that researches the efficacy of medical devices, has issued an alert about four brands of infusion pumps from Curlin Medical. The institute says the 2000 CMS, 4000 CMS, 6000 CMS, and PainSmart pumps present a risk of medication overinfusion. When engineers at ECRI Institute’s medical device laboratory tested the pumps, they found that doors on the pumps do not fully compress tubing during operation, which may result in intermittent gravity flow, releasing medication too quickly. There may be no visible indication that a pump permits gravity flow.
The institute says that volume testing is the only way to determine whether a particular pump has a door problem, and recommends that users perform such a test immediately, and every three months thereafter.
A federal jury has found that Boston Scientific Corp. must pay Medtronic Inc. $250 million for infringing on three patents related to catheters. Medtronic sued the company in 2006, stating that Boston Scientific’s Taxus Express2, Express2, Liberte, Maverick, Maverick2, and Quantum Maverick devices infringed on its Fitzmaurice and Anderson catheter patents. The Fitzmaurice patent involves angioplasty catheters that have narrowed distal ends to aid in delivering the catheter, and the Anderson patent concerns semicompliant angioplasty balloons that can withstand repeated inflations (for custom vessel sizing).
Since the jury decided that the infringement was intentional, the judge can raise the award to $750 million. A Medtronic spokesperson said that the company might even seek an injunction to stop the sales of the infringing products.
The device industry and its backers have made lots of money off minimally invasive surgery in the past 20 years. It is no surprise, then, that there would be a lot of interest in the next frontier: incision-free surgery. The Pioneer Press of St. Paul, MN has a feature about the potential of surgical procedures that don’t leave even a single scar. They are known as NOTES, which stands for natural orifice transluminal endoscopic surgery. Typically, they involve using the mouth, anus, or vagina as entry points into the body. Early applications are focusing on organ-removal procedures. If NOTES takes off, the procedures would likely be performed with existing endoscopic instruments that have been modified for use with natural orifices.
The question yet to be answered is how much these procedures benefit patients. Minimally invasive surgical procedures caught on after years of skepticism because they produced similar or better results as conventional surgeries with much less trauma to the patient. It’s not yet clear whether NOTES procedures will bring that kind of substantial improvement. But if they do, a number of companies will be ready to pounce.
Medtronic announced that it has reached an agreement with the Department of Justice to settle a “qui tam” case against Kyphon, which it bought in November 2007, for $75 million. The case against Kyphon concerned improper reimbursement advice it gave to customers regarding kyphoplasty procedures. The company also assented to a Corporate Integrity Agreement in which employees will be trained on how to give appropriate reimbursement advice and the firm will set up and maintain compliance procedures. Medtronic said it knew about the pending settlement when it acquired Kyphon, and Kyphon had already accounted for it.
DeviceTalk will return on Tuesday, May 27.
FDA today unveiled the Sentinel System, a series of databases that will allow it to query a broad array of information to identify possible post-market adverse events. Rather than waiting for adverse-event reports to trickle in, the agency will now be able to proactively search databases and look for problematic patterns of side effects and adverse events. If the system works as envisioned, the agency would be able to identify problems and alert doctors and patients to them much more quickly than it can now. This could prevent adverse events and save costs.
No patient-specific data will be returned in the searches, so privacy issues should not be a concern.
The effort will begin with a pilot program, using CMS’s Medicare Part D database. Eventually, FDA will also be able to search other CMS databases, and databases from the private sector — such as electronic medical records in hospital systems, and insurance-company databases.
The agency has prepared a white paper explaining how the system will work.
UPDATE: Thomas Gross, head of CDRH’s division of postmarket surveillance, confirmed that the new system will not bring any extra regulatory requirements upon the device industry.
AdvaMed said it supports the changes recently made to a Senate bill on disclosure to patients of doctors’ financial ties to drug and device companies. “This bill is an important step forward in improving transparency and does so in a manner that does not jeopardize future innovation. That’s good news for patients, physicians and industry,” said Stephen J. Ubl, president and CEO of AdvaMed.
The modifications include preemption of state disclosure laws to ensure consistency; requiring compliance by physician-owned manufacturers, distributors, and group purchasing organizations; and requiring disclosure information to be displayed in an easy-to-understand manner. AdvaMed would like to see one more change: exempting companies who pay less than $250,000 per year to physicians.
Georgia Tech researchers have designed an imaging tool that could help clinicians spot the severity of bruises at the point-of-care. It also has potential in diagnosing early stage tumors and cancer. The narrowband filter mosaic is a single-exposure device that would be used for multispectral imaging to provide subsurface characterization. Clinicians who use the device would be able to detect and evaluate how bad bruises and erythema are in real time, which can sometimes be a challenge in patients who have darker skin pigmentation. Better imaging will offer earlier detection of erythema, which could help stop the progression of pressure ulcers. It also has implications for earlier intervention in suspected cases of physical abuse.
The wallet-sized device has a filter that works at four or more wavelengths from visual to infrared, with 20-nm bandwidth in a single exposure. It can be laminated with the same imaging sensors that are used in digital cameras.
The researchers are looking for collaborators and funding to continue developing the device.
Certain kinds of carbon nanotubes triggered a cellular reaction in mice similar to that which leads to mesothelioma, a form of cancer, a study published in the online version of the journal Nature Nanotechnology reports. Nanotubes are used in a variety of consumer products, and some medical devices. This means that these materials will need to be handled very carefully, reports the Washington Post.
The findings do not apply to all nanotubes, nor do they necessarily predict effects on humans. And they are based on a small sample size. The effects were found only on the longest versions of nanotubes. And the mice were injected with the nanotubes, whereas humans would come into contact with them by inhaling them. The injections were made into the tissue around the lungs, and the longer nanotubes caused granulomas, which are cellular changes that can lead to cancer.
The study will lead to more research, as U.S. regulators do not have much of a handle on how to regulate nanomaterials. It could also lead to follow-up tests and guidance for workers at factories which produce nanotubes, since they are at the highest risk. Labeling to guide consumers and those who handle recycling on proper disposal could be in the cards as well.
FDA’s task force on nanotechnology did not believe that nanotechnology should change the way medical devices are regulated — and as alarming as the new study’s findings may be, there’s no reason to reassess that position. The reason is that medical device materials are already evaluated for toxicity. It is just a matter of taking the new information into account when doing those tests. Expect consumer groups, some of whom already wanted nanomaterials banned from the market until further research was done, to argue otherwise, however, and the mainstream media to print their arguments without questioning them much.
