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RenovoRx wins label expansion for RenovoCath device

March 31, 2017 By Sarah Faulkner

RenovoRx wins label expansion for RenovoCath deviceRenovoRx said yesterday that it won label expansion for the RenovoCath dual-balloon infusion catheter to include the delivery of chemotherapeutics. The device isolates segments of the peripheral vasculature, allowing doctors to deliver therapeutics in a more targeted fashion, according to the Los Altos, Calif.-based company.

“This additional FDA indication marks yet another milestone for RenovoRx as we continue to work towards making our technology available to physicians to treat difficult diseases,” CEO Shaun Bagai said in prepared remarks.

Previous work has shown that the targeted delivery of chemotherapy reduces overall side-effects compared to systemically-delivered chemotherapy. There is also evidence demonstrating that targeted delivery helps get higher concentrations of drug to the desired target within the body.

RenovoCath’s dual balloons can be inflated independently and doctors can adjuste the distance between the 2 balloons to isolate a treatment’s target, the company said. The adjustable length is a unique feature of RenovoRx’s device, which the company said reduces washout of the therapy and potential systemic side effects.

“This catheter technology is different in that there’s 2 balloons within a single catheter that can be inflated separately and has distinct lumens,” Dr. David Madoff, RenovoRx advisory board member, said. “You can adjust the length between the balloons to actually isolate and customize the area that you want to treat.”

Madoff has used the catheter to deliver drugs like chemotherapy, the company said, and described the RenovoCath as the “ideal catheter for targeted delivery.”

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Oncology, Regulatory/Compliance Tagged With: RenovoRx

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