November 2, 2020
Boston Scientific's Ranger DCB Receives FDA Approval
November 2, 2020—Boston Scientific announced it has received FDA approval for the Ranger drug-coated balloon (DCB), which was developed for the treatment of patients with peripheral artery disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).
The FDA approval is based on results from the RANGER II SFA pivotal trial, which evaluated the safety and effectiveness of the Ranger DCB versus standard percutaneous transluminal angioplasty (PTA) for the treatment of patients with PAD in the SFA and PPA.
In the randomized controlled trial, both primary endpoints were met. As summarized in the announcement, the results included the following:
- The primary safety endpoint of 12-month freedom from major adverse events (MAE) was 94.1% for those treated with the Ranger DCB versus 83.5% for standard PTA (Pnoninferiority< .0001).
- Additionally, patients who received therapy with the Ranger DCB had a significantly lower target lesion revascularization rate—a component of MAE—of 5.5% in contrast to 16.5% observed with standard PTA (P = .0011), substantially reducing a patient's need for repeat procedures.
- The primary efficacy endpoint of 12-month binary primary patency—a measure of the target vessel remaining unobstructed—was 82.9% for the Ranger DCB and 66.3% for standard PTA (P = .0017). Primary patency by Kaplan-Meier estimate was 89.8% for the Ranger DCB and 74% for PTA at 12 months (P = .0005).
The principal investigator of the RANGER II SFA trial is Ravish Sachar, MD, who is Physician-in-Chief for Heart and Vascular services at UNC Rex Hospital in Raleigh, North Carolina.
"The Ranger DCB eases deliverability for a wide range of lesion complexities via a low-profile platform that is compatible with smaller diameter guidewires and has shown consistent results in multiple randomized controlled trials," commented Dr. Sachar in the approval announcement. "For physicians seeking to limit systemic drug loss without compromising outcomes, data demonstrate the Ranger DCB is a safe and effective treatment option."
According to the company, the Ranger DCB was designed with a low therapeutic drug dose and the company's coating, which efficiently transfers the drug into the tissue, resulting in high primary patency rates and low systemic drug exposure for patients. Boston Scientific reported that the Ranger DCB demonstrated approximately 90% primary patency in the investigator-sponsored COMPARE head-to-head prospective, randomized controlled trial to compare two different DCBs. In the trial, the Ranger DCB demonstrated a similar primary patency rate of 88.4% to that of the 89.4% observed with In.Pact Admiral DCB (Medtronic) by Kaplan-Meier estimate (P = .81), with a significantly lower drug dose density (2 µg/mm2paclitaxel versus 3.5 µg/mm2 paclitaxel, respectively).
The company expects to initiate a registry of the Ranger DCB and the Eluvia stent in the coming months to gather additional real-world evidence, which will add to the breadth of clinical data collected on these devices to date. The registry is expected to include 5 years of patient follow-up with an emphasis on enrolling patient populations who have been historically underrepresented in clinical trials studying treatments for PAD, stated Boston Scientific.
The Ranger platform received European CE Mark in 2014. Boston Scientific plans to immediately launch the device in the United States.