HistoSonics Edison system gains early market access in the U.K.
HistoSonics announced last week that its Edison histotripsy system for noninvasively destroying liver tumors has secured limited U.K. market access.
According to the Plymouth, Minn.–based company, the Medicines and Healthcare Products Regulatory Agency in Great Britain granted controlled early limited market access under an Unmet Clinical Need Authorisation available through the U.K.’s Innovative Devices Access Pathway (IDAP) program.
The Edison system was one of just eight available application spots in 2024, HistoSonics said.
“Securing GB-controlled access through the IDAP pilot program is a tremendous milestone for HistoSonics and signals clear recognition of our technology’s potential to transform healthcare,” stated HistoSonics CEO Mike Blue. “We are honored to work alongside the NHS and U.K. regulatory and access partners to bring histotripsy to patients across the U.K., many of whom have limited options. This progress builds on our strong clinical track record in the U.S. and our growing base of clinical evidence globally.”
The Financial Times reported last month that HistoSonics is considering a potential sale after receiving several offers from major medical technology companies.
Edison uses ultrasound energy to target tumors
The Edison system uses focused ultrasound energy to provide histotripsy therapy. Delivered via a robotic arm, the non-thermal, non-invasive focused ultrasound technology mechanically destroys and liquifies targeted tissue and tumors, without the invasiveness or toxicity of traditional procedures.
HistoSonics noted that physicians who have completed company-provided training should only use the device. The clinical judgment of a qualified and appropriately trained physician should always guide its use, it added.
Edison received de novo clearance from the U.S. Food & Drug Administration in October 2023.
HistoSonics gets first insurance coverage
Also last month, HistoSonics secured its first major insurance coverage for Histotripsy. Blue Cross Blue Shield of Michigan (BCBSM) and Blue Care Network created a new medical policy for histotripsy of the liver. The policy covers non-thermal histotripsy using the Edison Histotripsy System for the treatment of primary and metastatic liver tumors.
This means, as of Feb. 1, 2025, histotripsy is a reimbursable procedure for the non-invasive mechanical destruction of liver tumors under CPT code 0686T. This gives eligible patients in Michigan early access to this incisionless treatment ahead of the broader policy’s effective date of July 1.
To date, more than 50 leading medical centers across the U.S. have adopted the Edison Histotripsy System. Surgeons, radiologists, and oncologists have used it to treat over 1,500 patients, claimed HistoSonics.
Editor’s note: This article was syndicated from The Robot Report sibling site MassDevice.
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