Health Canada seems to be on a roll as it recently approved two devices within days of each of other. One approval is for a system designed to enhance the safety of donated blood and the other is a for a platform for treating essential tremor.
Close is only good in horse shoes
Essential tremor is a movement disorder that affects millions worldwide. Nearly as arduous for some patients, Richard Schallhorn, vice president of neurosurgery at Insightec, told Medical Device Daily has been the means of treating it: the surgeon drills holes into the patient's head, inserts probes into the brain and then lesions the affected areas.
Insightec, of Tirat Carmel, Israel, makes the Exablate Neuro, the device that just won approval in Canada.
"With Exablate Neuro, we can create that lesion without opening the skull," Schallhorn said.
The device combines therapeutic focused ultrasound, which ablates targeted tissue deep within the brain, and MRI, which guides the ultrasound waves to precisely target those tissue sites. "Taking a blind shot is not an option," Schallhorn said. "Using this technology you can apply just the right amount of heat and put it in exactly the place you need it."
Better yet, he said, because the procedure is in done in real time while the patient is conscious, "we can absolutely verify that we're in the right place."
"By being able to evaluate patients while they're awake, before we've heated it up to a level of destroying tissue is what allows us to do this surgery safely and effectively," Schallhorn said.
Exablate Neuro is approved for sale in Europe, but is restricted for investigational purposes elsewhere. Health Canada relied on data from randomized control trials involving 75 patients at eight research centers around the world, the same data the FDA and regulatory agencies in Japan and other countries will use for their review of the device.
A privately financed company, Insightec has relied on "a good $200 million" of investments to develop the technology, Schallhorn said. He puts the purchase price to hospitals for Exablate Neuro at about US$1.5 million.
Casting a wider net for safer blood
It's estimated that more than 300,000 units of plasma are used in transfusion annually in Canada. Currently, the safety of that supply is secured through donor questionnaires about their overall health, illicit drug use and sexual activity, and tests for specific infectious agents such as West Nile virus, HIV, hepatitis C and B. That, Kevin Green, CFO of Cerus Corp., told MDD, poses a problem.
"You have to know that the bug exists and is present and then develop a particular assay test for that specific pathogen," Green said. "That approach has served us well but it's a very reactive approach."
By contrast, the Intercept blood system developed by Cerus, of Concord, Calif., is proactive technology designed to enhance the safety of the nation's blood supply by exploiting the differences between different components within the blood. Health Canada approved the device earlier this month.
Green said platelets, plasma and red blood cells do not require functional DNA or RNA. Pathogens such as bacteria, viruses, parasites and harmful white blood cells, however, need DNA or RNA to replicate and to infect. Intercept employs a molecule called amotosalen HCl to bind to and block the replication of DNA and RNA in the blood. Green likened it to "spot welding a zipper."
"The small molecule intercalates with the nucleic acid strand and when it's exposed to ultraviolet A light that 'spot welder' is activated so that the nucleic acid strand is not able to split apart and replicate."
The device already has U.S. and European approval and now the Health Canada approval will allow Cerus to introduce the system to Canada's two blood donor agencies, Canadian Blood Services and Héma-Québec, Green said.
Cerus initially partnered with St. Paul, Minn.-based Baxter Corp. to develop the system, Green said, to the tune of "close to a billion dollars."