The histotripsy process. | Supply: Screenshot taken from a HistoSonics video
HistoSonics introduced final week that its Edison histotripsy system for noninvasively destroying liver tumors has secured restricted U.Okay. market entry.
In keeping with the Plymouth, Minn.–based mostly firm, the Medicines and Healthcare Merchandise Regulatory Company in Nice Britain granted managed early restricted market entry beneath an Unmet Scientific Want Authorisation obtainable via the U.Okay.’s Revolutionary Gadgets Entry Pathway (IDAP) program.
The Edison system was certainly one of simply eight obtainable utility spots in 2024, HistoSonics stated.
“Securing GB-controlled entry via the IDAP pilot program is an incredible milestone for HistoSonics and alerts clear recognition of our expertise’s potential to rework healthcare,” said HistoSonics CEO Mike Blue. “We’re honored to work alongside the NHS and U.Okay. regulatory and entry companions to carry histotripsy to sufferers throughout the U.Okay., lots of whom have restricted choices. This progress builds on our robust scientific observe report within the U.S. and our rising base of scientific proof globally.”
The Monetary Occasions reported final month that HistoSonics is contemplating a possible sale after receiving a number of presents from main medical expertise firms.
Edison makes use of ultrasound power to focus on tumors
The Edison system makes use of targeted ultrasound power to supply histotripsy remedy. Delivered by way of a robotic arm, the non-thermal, non-invasive targeted ultrasound expertise mechanically destroys and liquifies focused tissue and tumors, with out the invasiveness or toxicity of conventional procedures.
HistoSonics famous that physicians who’ve accomplished firm-provided coaching ought to solely use the machine. The scientific judgment of a certified and appropriately skilled doctor ought to all the time information its use, it added.
Edison obtained de novo clearance from the U.S. Meals & Drug Administration in October 2023.
HistoSonics will get first insurance coverage protection
Additionally final month, HistoSonics secured its first main insurance coverage protection for Histotripsy. Blue Cross Blue Defend of Michigan (BCBSM) and Blue Care Community created a brand new medical coverage for histotripsy of the liver. The coverage covers non-thermal histotripsy utilizing the Edison Histotripsy System for the therapy of main and metastatic liver tumors.
This implies, as of Feb. 1, 2025, histotripsy is a reimbursable process for the non-invasive mechanical destruction of liver tumors beneath CPT code 0686T. This provides eligible sufferers in Michigan early entry to this incisionless therapy forward of the broader coverage’s efficient date of July 1.
Up to now, greater than 50 main medical facilities throughout the U.S. have adopted the Edison Histotripsy System. Surgeons, radiologists, and oncologists have used it to deal with over 1,500 sufferers, claimed HistoSonics.
Editor’s word: This text was syndicated from The Robotic Report sibling web site MassDevice.
Now accepting session submissions!