FDA okays Insightec's MR-guided focused ultrasound with Siemens scanners

September 26, 2018
by Thomas Dworetzky, Contributing Reporter
Insightec has expanded its reach as it has announced that the FDA has approved its Exablate Neuro as compatible with the Magnetom Skyra, Prisma and Prisma Fit from Siemens Healthineers MR scanners for the treatment of essential tremor.

"This important milestone is directly attributed to the commitment and collaboration of the teams at Insightec and Siemens Healthineers, who met the challenge head-on," Insightex CEO Dr. Maurice R. Ferré, said in a statement. "Expansion of MR compatibility for Exablate Neuro substantially increases the potential reach of incisionless brain surgery for essential tremor patients."

The Exablate Neuro will be able to use the Siemens scanners' image guidance to precisely target tissue in order to ablate it inside the brain with no incision. To date, it has been used to treat over 1,500 essential tremor patients.

The new compatibility approval is another move by Siemens to grow its presence in the neurology space, where clinical trials continue to evaluate other neurological disease applications, according to Dr. Christoph Zindel, senior vice president and general manager for magnetic resonance at Siemens. He noted that the joint development “underlines our commitment to expanding precision medicine,” and will enable the company to offer focused ultrasound more widely to the hospital community.

A present, the Exablate is being installed on a Magnetom Skyra from Siemens Healthineers at University of Utah Health. "The expansion of Exablate Neuro to be compatible with Siemens Healthineers MRs will broaden access for patients to an incisionless treatment option,” stressed Dr. Satoshi Minoshima, professor and chair of the Department of Radiology and Imaging Sciences at the university.

In other Siemens Healthineers news just breaking today, the company announced that it was forming a sales partnership for urology with Storz Medical at the 70th Congress of the German Society for Urology in Dresden.

The partnership will let both companies market each other’s systems, including Siemens Cios family mobile C-arms and shock wave lithotripsy system Modulith from Storz.

“Working with Siemens Healthineers, we can make our expertise in urology available to a broader range of customers and offer comprehensive solutions,” said Storz CEO Dr. Gerold Heine in a statement.

The move underscores the importance of the urology sector to both firms, according to Peter Schardt, head of X-ray Products at Siemens Healthineers, who noted that, “together, we can facilitate access to the best possible diagnostic and therapy solutions for our customers and their patients.”

In June, Insightec made news when Medicare extended benefit coverage in 10 U.S. states for MR-guided focused ultrasound (MRgFUS) for the treatment of essential tremor. Six more states will follow on July 1, 2018, the company said in a statement at the time, adding that other Medicare administrative contractors have issued positive draft local coverage determinations, which could bring the total to 38 states.

"The decision from these Medicare Administrative Contractors to cover Insightec's MRgFUS essential tremor treatment is a welcome recognition of the clinical and economic benefits of incisionless brain surgery for people living with essential tremor," said Ferré, who added that, "by formalizing insurance coverage, Medicare is expanding access to focused ultrasound for many more patients and physicians."

And in February, Virginia Tech Carilion Research Institute (VTCRI) announced that it would become the first nonclinical research environment to use the Exablate Neuro, paired with Siemens MR imaging, to explore possible treatments for brain cancers and psychiatric disorders.

"We share a common vision, a culture of discovery and openness, and a commitment to study and develop scientifically validated technological innovations, to treat patients with otherwise untreatable brain disorders," Michael Friedlander, VTCRI executive director and Virginia Tech's vice president for health sciences and technology, said in a statement at the time.