Paclitaxel-coated (percutaneous transluminal angioplasty) PTA balloon catheter
Boston Scientific’s Ranger Drug-Coated Balloon (DCB) is a Paclitaxel-coated balloon catheter developed to perform percutaneous transluminal angioplasty (PTA) to treat peripheral artery disease (PAD) in the superficial femoral (SFA) and proximal popliteal (PPA) arteries.
The company received European CE Mark for the Ranger DCB in July 2014 and secured the Food and Drug Administration (FDA) approval in November 2020.
PAD is a common circulatory disease that affects approximately 200 million people worldwide. It narrows arteries due to plaque build-up and leads to a subsequent reduction of blood flow to limbs.
The affected limbs may require amputation in severe PAD cases.
Ranger DCB includes proprietary TransPax coating technology formulated from Paclitaxel (PTx) and a citrate ester excipient. The coating technology ensures optimal drug transfer to the intended vessel’s tissue and ensures consistent, therapeutic dose of Paclitaxel.
TransPax coating has a balanced hydrophobic and hydrophilic properties, which facilitates the balloon to reach the lesion with an optimal therapeutic dose of Paclitaxel and reduces systemic loss.
Ranger has a pre-mounted loading tool that ensures drug coating integrity and simplifies handling while inserting the device through a tight introducer’s valve. It shifts over the balloon once the balloon protector is removed.
The Paclitaxel-coated PTA balloon catheter is based on the well-known 0.018″ Sterling balloon dilatation catheter platform with .018″ or .014″ guide wire compatibility and the lowest tip entry profile, adding to ease of deliverability. The smaller diameter guide wires can be used across a wide variety of lesion complexities.
Ranger DCB’s Sterling platform has outstanding pushability and trackability, which enables navigation through substantially difficult anatomies.
Ranger has a broad size matrix with longer sizes of 120mm, 150mm, and 200mm.
Designed with a low therapeutic dosage and proprietary coating, the device results in high primary patency rates and low systemic drug toxicity for patients. It is an important tool to treat lesions both above and below the knee.
The FDA approval of the Ranger drug-coated balloon catheter was based on the outcomes of a global, prospective, multi-centre, and pivotal clinical trial called RANGER II SFA.
The trial compared the safety and efficacy of Ranger DCB to the standard PTA for the treatment of PAD in patients.
A total of 440 patients were enrolled and randomised in 3:1 ratio to receive PTA, using the Ranger DCB or standard angioplasty balloon.
In the primary safety outcome, approximately 94.1% of patients treated using the Ranger DCB were free from major adverse events (MAE) at the end of 12 months, compared to 83.5% of patients treated using standard PTA.
Further, the patients who received Ranger DCB therapy had lower revascularisation rate of target lesions (5.5%), which is an MAE component, compared to 16.5% observed in patients treated using standard PTA, significantly reducing the need for repeat procedures for a patient.
In the primary efficacy outcome, the 12-month binary primary patency, which is a measure of the remaining unobstructed target vessel, was evaluated. The Ranger DCB demonstrated 82.9% primary patency compared to 66.3% for the standard PTA at 12 months.
The Kaplan-Meier primary patency estimate was 89.8% for the Ranger DCB and 74.0% for the PTA at 12 months.
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