AngioDynamics Receives FDA Approval to Initiate NanoKnife® DIRECT Clinical Study for the Treatment of Stage III Pancreatic Cancer
The DIRECT Study supports a proposed expanded indication for the
NanoKnife System in the treatment of Stage III pancreatic cancer. In
“The DIRECT study design demonstrates our commitment to provide an
option that addresses a pressing unmet need for patients with Stage III
pancreatic cancer,” said
The NanoKnife System is a next-generation ablative technology that physicians have identified as an innovative treatment for pancreatic cancer, as evidenced by 42 publications documenting more than 800 patients that have been treated for Stage III pancreatic cancer with NanoKnife technology between 2012 to 2019.
The NanoKnife System received 510(k) clearance from the FDA for the surgical ablation of soft tissue in 2008. Unlike other ablative technologies, the NanoKnife System utilizes low-energy, direct-current electrical pulses to permanently open pores in target cell membranes and does not rely on thermal effects. These permanent defects in the cell membranes result in cell death. The treated tissue is then removed by the body's natural processes in a matter of weeks, mimicking natural cell death.
AngioDynamics’ DIRECT study will feature a comprehensive data collection
strategy that will provide meaningful clinical information to healthcare
professionals, support a regulatory indication for the treatment of
Stage III pancreatic cancer, and facilitate reimbursement for hospitals
and treating physicians. The next-generation study is classified as a
Category B IDE by the
The DIRECT study comprises a Randomized Controlled Trial (RCT) at up to
15 sites and a real-world evidence, next-generation registry (RWE) at up
to 30 sites, each with a NanoKnife System treatment arm and a control
The RCT component of the DIRECT study will illustrate the promise of the NanoKnife System by isolating variables in a controlled setting. Recognizing that results from a hyper-controlled setting do not always translate to clinical practice, the study also includes a RWE component to provide clinicians, patients, and payors with data generated in a real-world setting.
As part of the DIRECT clinical study,
“Existing evidence that has accumulated over the last 10 years has shown
that Irreversible Electroporation is an effective adjunctive treatment
for patients with locally advanced pancreatic cancer,” said Dr.
“I’ve had promising experience utilizing Irreversible Electroporation as
a treatment option for pancreatic cancer patients,” said Dr.
There are approximately 57,000 new cases and 46,000 estimated deaths
from pancreatic cancer in
There are limited treatment options for Stage III and IV disease, with chemotherapy and/or radiotherapy considered the standard of care3. There have been advancements in both techniques, but this has come at the cost of greater toxicity3, limiting the number of patients that are candidates for treatment.
About the NanoKnife System
The NanoKnife System has received 510(k) clearance from the Food and Drug Administration for the surgical ablation of soft tissue. The NanoKnife Ablation System utilizes low energy direct current electrical pulses to permanently open pores in target cell membranes. These permanent pores, or nano-scale defects, in the cell membranes result in cell death. The treated tissue is then removed by the body's natural processes in a matter of weeks, mimicking natural cell death. Unlike other ablation technologies, the NanoKnife Ablation System does not achieve tissue ablation using thermal energy.
The NanoKnife Ablation System consists of two major components: a Low Energy Direct Current, or LEDC Generator and needle-like electrode probes. Up to six (6) electrode probes can be placed into or around the targeted soft tissue. Once the probes are in place, the user enters the appropriate parameters for voltage, number of pulses, interval between pulses, and the pulse length into the generator user interface. The generator then delivers a series of short electric pulses between each electrode probe. The energy delivery is hyperechoic and can be monitored under real-time ultrasound.
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2 Projecting Cancer Incidence and Deaths to 2030: The Unexpected Burden of Thyroid, Liver, and Pancreas Cancers in