J&J gets FDA breakthrough status for robot-assisted ablation device

Dive Brief:

Johnson & Johnson has secured FDA breakthrough device designation for transbronchial microwave ablation technology using robot-assisted bronchoscopy, the company disclosed on Thursday.
J&J moved into microwave ablation in 2016 through the takeover of NeuWave Medical. Three years later, J&J added a lung-focused robotic surgery platform in the $3.4 billion acquisition of Auris Health. The medical device covered by the breakthrough designation combines technologies from the two acquisitions.
Securing FDA breakthrough designation positions J&J to benefit from extra regulatory support and potentially a speedy review as it tries to bring the system to market.

Dive Insight:

In recent years, J&J has entered into a series of deals to gain potentially complementary technologies related to robotic surgeries. The planned combination of technologies developed by Auris and Verb Surgical, the joint venture with Alphabet’s Verily Life Sciences that J&J bought out last year, is one of the more high-profile examples but not the only area of overlap between the acquired assets.

As the breakthrough designation shows, J&J is also working to combine the NeuWave microwave ablation system with the Monarch surgical platform it acquired in the takeover of Auris.

The microwave ablation system is already used in minimally invasive procedures to ablate soft tissue lesions. To date, surgeons have used the device in more than 45,000 procedures. Existing versions of the technology are cleared for use in open, percutaneous, endoscopic and laparoscopic procedures.

Combining the ablation system with the Monarch platform would enable surgeons to ablate tissue while performing robot-assisted bronchoscopy. J&J is pitching the platform as a way for surgeons to reach deeper into the lung and move a probe through small, hard-to-navigate areas.

News of the designation follows changes to J&J’s R&D plans. J&J filed to run two clinical trials of its transbronchial microwave ablation system in 2018. However, J&J suspended one trial pending a protocol amendment in 2019. J&J withdrew the other trial in May, citing “changed study design prior to any patients enrolled” to explain the action. Neither protocol refers to robotics, simply stating the procedure will be performed by “an interventional pulmonologist or thoracic surgeon using CT imaging.”

J&J is one of a number of companies to receive a breakthrough designation in recent weeks. Solenic Medical secured the status for its use of alternating magnetic fields to treat prosthetic joint infections. Revamp Medical received the designation for its acute heart failure treatment. FDA also granted the privileges to Envoy Medical’s fully implanted Acclaim cochlear implant and preCARDIA’s treatment for volume overload in patients with acutely decompensated heart failure.