FDA Grants New 510(k) Clearance to RenovoCath Delivery System for Targeted Treatment of Solid Tumors

RenovoCath, which was granted a new 510(k) clearance by the FDA, distributes chemotherapy directly to solid tumors via the arteries, opening avenues for a more targeted treatment.

The RenovoCath Delivery System, a device component of RenovoGem that is designed for the targeted treatment of solid tumors, received a new 510(k) clearance from the FDA, according to a press release from RenovoRx, Inc.1

The drug/device combination used in RenovoRx's Trans-Arterial Micro-Perfusion (RenovoTAMP) platform is a dual-balloon infusion catheter that delivers chemotherapy through the arteries directly to solid tumors. The new design is able to provide more targeted delivery of therapy for this population of patients that may result in fewer adverse effects (AEs).

According to the press release, a 510(k) clearance is a “premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device.”

“Our novel RenovoTAMP therapy platform isolates the region of disease, enabling delivery of the optimal dose of targeted chemotherapy to the tumor location,” Shaun Bagai, chief executive officer at RenovoRx, said in a press release. “We believe this new design cleared through the FDA 510(k) process will further improve RenovoTAMP's targeted delivery. Our focus is maximizing patient survival while minimizing side effects for [patients with] cancer.”

The novel therapy platform designed to deliver chemotherapy as a localized treatment of solid tumors, RenovoTAMP, is under clinical investigation in the phase 3 TIGeR-PaC study (NCT03257033), which aims to assess whether the delivery method yields an increase in survival and improvement in quality of life. The randomized clinical trial will utilize the RenovoTAMP platform to evaluate RenovoGem, which will deliver intra-arterial gemcitabine through the novel delivery system.

The study achieved 44% of its total patient enrollment as of August 15, 2021. The treatment will be administered to a population of patients with pancreatic cancer. The study continues to enroll patients with locally advanced pancreatic cancer, with an expected total population of approximately 200 patients.

Patients with locally advanced pancreatic cancer who enroll on the trial will be treated with induction gemcitabine plus nab-paclitaxel and radiotherapy for 4 months followed by intra-arterial gemcitabine for 16 weeks or until disease progression. In order to be enrolled on the trial, patients needed to have histologically- or cytopathology-confirmed, locally advanced or unresectable pancreatic adenocarcinoma. Patients were required to have an ECOG performance status of 0 or 1, an absolute neutrophil count of 1500/μL or more, and a platelet count of 100,000/μL or more.

The primary outcome measure of the trial is overall survival, with key secondary outcome measures including progression-free survival, objective response rate and duration of response, and health-related quality of life.

Previous findings from a phase 1/2 study that assessed the safety of RenovoTAMP system to deliver chemotherapy to patients with locally advanced pancreatic cancer indicated that the treatment yielded a CA 19-9 tumor marker reduction in 58% of patients. Additionally, the survival rate of 12-months was 60%. Serious AEs included sepsis (n = 3), grade 3 neutropenia (n = 3), guide-mediated vascular dissection (n = 3), and pulmonary toxicity (n = 1). Overall, the study demonstrated feasibility of localized and selective intra-arterial chemotherapy delivery using the RenovoCath Delivery System.2

The RenovoCath platform received its initial 510(k) clearance from the FDA in 2014.


  1. RenovoRx receives new 510(k) clearance for its RenovoCath® delivery system designed for targeted treatment of solid tumors. News release. RenovoRX. September 7, 2021. Accessed September 7, 2021. https://tinyurl.com/yzxa9muf
  2. Rosemurgy AS, Ross SB, Vitulli PL et. al. Safety study of targeted and localized intra-arterial delivery of gemcitabine in patients with locally advanced pancreatic adenocarcinoma. J Pancreat Cancer. 2017;3(1):58-65. doi:10.1089/pancan.2017.0011
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