Every year, 260 000 people in Europe and the United States undergo a craniotomy to have a brain tumour removed or to treat a brain injury or lesion. This complicated surgery involves exposing the brain by removing part of the bone, called the bone flap, from the skull. After the surgery is complete, this bone flap is replaced using implants made of plastics and titanium mesh. Unfortunately, these materials are not transparent to ultrasound (US). This is problematic because US is the most effective method for physicians to monitor the brain post surgery. To ensure doctors can ‘see through’ the bone flap, one Italian company has developed INTRA, the world’s first US-transparent implantable prosthesis for neurosurgical procedures. “INTRA makes it possible to use ultrasonography on the brain and to increase the effectiveness of drugs aimed at treating brain diseases,” says Gianpietro Pasquon, a researcher at Intelligenza Trasparente, an Italian start-up specialising in biomedical engineering and neurosurgical image-processing. Intelligenza Trasparente developed INTRA with the support of EU funding and in close partnership with the Carlo Besta Institute in Milan and the University of Virginia’s Focused Ultrasound Foundation.
New approaches to treating cancer
Due to the inability to use US for brain imaging, most doctors have resorted to using MRI scans for post-surgical diagnostic follow-ups and for assessing the effectiveness of such cancer treatments as chemotherapy. However, MRI scans are extremely expensive and of limited availability, meaning patients must wait – even when time is of the essence. US scans, on the other hand, offer the same imaging efficacy as MRIs but at a much lower cost. They’re also readily available in nearly every hospital and clinic. Despite some initial issues with manufacturing a biocompatible prosthesis, INTRA project researchers were able to find a solution thanks to a better integration of the supply chain. “Our prototype prosthetic will enable new approaches to treating cancer and other neurodegenerative diseases that, without the use of US, were simply impossible,” explains Pasquon. “Having the ability to perform such advanced imaging techniques as high-intensity focused US will make it possible for neurological patients to get the fast, affordable diagnosis they need to effectively treat brain tumours.”
First human implant a success
The INTRA prototype underwent full testing during the project, including on an actual human patient. “This ‘first human implant’ test demonstrated the feasibility of using INTRA on humans,” says Pasquon. “It was dramatic to be able to see a real-time image of the patient’s brain with ultrasonography.” Pasquon notes that prior to the implant, doctors had given the patient little chance of survival. However, post-surgery, he continues to do unexpectedly well. “This makes us extremely proud,” adds Pasquon. Intelligenza Trasparente is currently working to advance the clinical trial programme – a prerequisite to getting INTRA certified as a medical device and put onto the market in the EU and United States. To ensure the product is made available to patients as quickly as possible, the team is already preparing a consolidated business model aimed at streamlining the marketing and distribution strategy.
INTRA, ultrasound, brain cancer, neurosurgical procedures, craniotomy, bone flap, ultrasonography, MRI