Each year 750,000 Americans suffer from stroke. It's the third leading cause of death in the U.S. and the leading cause of long-term disability.
But a staple-sized neurostimulator could prove itself to be a huge breakthrough in the treatment of ischemic stroke. Or at least that's what Brainsgate (Caesara, Israel) and researchers involved in a clinical trial evaluating the device are hoping.
The miniature neurostimulator is a doughnut-shaped transmitter that's placed in the patient's mouth near the sphenopalatine ganglion, a nerve located in the roof of the mouth. A steady stream of electrical stimulation is then delivered for several hours a day throughout a five day-period. The effect of stimulating the sphenopalatine ganglion leads to the arteries dilating so that more blood flow is delivered to the stroke-affected hemisphere of the brain.
The tiny device, which is vying for FDA approval, is then removed from the patient's mouth.
What the company and researchers are trying to prove in the Impact-24 clinical trial, is that the device can treat patients without serious side effects.
"If this treatment is successful, it would be a major advancement in stroke treatment," David Chiu, MD, medical director of the Eddy Scurlock Stroke Center and the study's primary investigator at Methodist Neurological Institute (Houston) told Medical Device Daily. "It could also substantially increase the number of stroke patients we'll be able to treat."
The device will hopefully allow for an enhanced window of time for the effective treatment of stroke. Currently, that window is up to four hours with the use of an FDA approved drug known as tPA.
"TPA is a clot busting drug, if you go beyond the recommended four hours, it doesn't work," he said. "Plus using the drug is a double edged sword because there's always the risk of brain hemoharrage that accompanies using it for treatment."
Brainsgate's device is much more suitable, according to Chiu, because it has been shown to have very minimal side effects.
"Patients sometimes feel a bit of a tingle on the side of their face or in their mouth, but nothing serious," he added.
The trial is a multicenter, randomized, double blind study taking place worldwide over the next two years. Methodist said it was one of six locations in the country to offer this study. To date about four patients have been implanted with the device at Methodist.
If the study has positive results then the FDA could possibly broaden the trial to include more patients in the U.S.
"We're always involved in trying to push the envelope of what we can do to help our stroke patients," Chiu said.
Brainsgate has recently seen a great deal of significant activity. In August the company, which bills itself as a developer of a therapeutic platform technology based on electrical neurostimulation, reported the completion of a $27.5 million Series C financing round in which both new and existing investors participated (Medical Device Daily, August 14, 2008).
Johnson & Johnson Development led the round, joined by VC-Fund Agate Medical Investments, headed by former Israeli Minister of Health Danny Naveh. Existing investors who also participated in the current round included Elron Electronic Industries (Tel Aviv), Pitango Venture Capital, MB Venture Capital and Alice Lab.
If Brainsgate continues its success and gets its device approved by the FDA it could enter into a growing treatment and prevention market.
Invatec (Roncadelle, Italy) has developed a cerebral protection device that can be used during CAS procedures to prevent debris from reaching the brain. The company received FDA 510(k) clearance for its Mo.Ma Ultra Proximal cerebral protection device for use during CAS (MDD, Oct. 26, 2009). According to the company, the device reduces and captures debris released during the stenting. The company also said it has completed the ARMOUR trial, which demonstrated low stroke and major adverse cardiac and cerebrovascular event rates.
W. L. Gore & Associates (Flagstaff, Arizona) makes a device that was approved earlier this year by the FDA. The Gore Flow Reversal System is designed to reverse the flow of blood during stenting procedures. According to Gore, its neuroprotection technology reverses the flow of blood at the treatment site prior to crossing the lesion so there's almost no chance that particles could escape to the brain (MDD, Feb. 11, 2009).
Omar Ford, 404-262-5546;