Boston Scientific has secured FDA approval for its Ranger paclitaxel-coated balloon, designed to help limit a patient’s systemic exposure to the chemotherapy used to slow the closure of reopened arteries.
The slim-profile balloon includes a lower overall dose of the embedded drug, as well as a proprietary coating that transfers the compound into adjacent tissue to help stop its spread throughout the body.
The Ranger previously received a CE Mark in 2014; Boston Scientific said it plans to immediately begin the U.S. rollout of the device. The agency approved the balloon to treat peripheral artery disease in the femoral artery of the upper thigh and the popliteal artery that runs behind the knee, where narrowing vessels can restrict blood flow to the legs.
The FDA’s green light was based on a randomized clinical trial that compared the Ranger to standard percutaneous transluminal angioplasty performed in the same arteries.
After one year, fewer people saw serious side effects after the procedure, at 5.9% of those treated with the Ranger balloon compared to 16.5% receiving the drugless intervention, the company said.
RELATED: Though sales are up, Boston Scientific's net Q1 profit shrinks to $11M in the face of COVID-19
In addition, the paclitaxel-coated balloon helped reduce the need for repeat procedures, with 5.5% undergoing lesion revascularization compared to 16.5%, a figure included in the aforementioned total of major adverse events.
Overall, 82.9% patients treated with the Ranger balloon had their blood vessels stay open after one year, compared to 66.3% under standard angioplasty.
A separate clinical trial compared Boston Scientific’s device to Medtronic’s IN.PACT Admiral drug-coated balloon, showing similar rates of primary blood vessel patency—88.4% and 89.4%, respectively—with lower doses of embedded paclitaxel, at 2 micrograms per square millimeter of the balloon’s surface compared to 3.5.
Boston Scientific also said it plans to launch a registry to track the outcomes of people undergoing treatment with the Ranger balloon, as well as with its Eluvia paclitaxel-eluting stent, to gather real-world data for at least five years.