INSUBCONTINENT EXCLUSIVE:
The histotripsy procedure
| Source: Screenshot taken from a HistoSonics videoHistoSonics 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 tumorsThe 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
Food & Drug Administration in October 2023.HistoSonics gets first insurance coverageAlso 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
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.Now accepting session submissions!The post HistoSonics Edison system gains early
appeared first on The Robot Report.
