First Hospital in the State to Successfully Deploy the Ranger Drug Coated Balloon™
MISSOURI DELTA MEDICAL CENTER HAS BECOME THE FIRST HOSPITAL IN THE STATE OF MISSOURI TO SUCCESSFULLY DEPLOY THE BOSTON SCIENTIFIC RANGER DRUG COATED BALLOON™
SIKESTON, MO, December 15, 2020: Missouri Delta Medical Center now offers the Boston Scientific Ranger drug coated balloon (DCB), which was developed for the treatment of patients with peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA). The newly US Food and Drug Administration (FDA) approved Ranger DCB provides physicians with a safe and effective option to treat PAD, which impacts more than 8.5 million American adults. It is a common circulatory problem in which atherosclerosis builds and narrows arteries, consequently reducing blood flow to limbs. It is estimated that 12 to 14% of the general population is affected by PAD. The Ranger DCB was designed with a very low dose of drug and a proprietary coding, which efficiently transfers drug into the tissue, resulting in high primary patency rates and low systemic drug exposure for patients. The low-profile platform of the balloon also assists clinicians in performing streamlined procedures and navigating through challenging anatomy in order to deliver consistent therapy. The first patient implant at Missouri Delta Medical Center was performed on December 10, 2020 by cardiothoracic surgeon, Dr. Paula Guinnip. She stated that, “Improvements in patency were a real benefit in considering the use of this effective balloon.” Clinical trial results have demonstrated the Ranger DCB’s safety and efficacy versus standard percutaneous transluminal angioplasty (PTA) with 12 month freedom from major adverse events (MAE) being 94.1% for those treated with Ranger DCB versus 83.5% for standard PTA and 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. The COMPARE trial is the world’s first head to head randomized controlled trial
(RCT) comparing low-dose Ranger to a higher dose as studied in the IN.PACT trial. Ranger demonstrated similar primary patency as IN.PACT, with a significantly lower drug dose density. The company announced CE Mark for Ranger DCB in 2014 and the FDA granted regulatory approval on November 2, 2020. For more information on the Ranger DCB, visit https://www.boston scientific.com/en-US/medical-specialties/vascular-surgery/drug-eluting therapies/ranger.html.
What is PAD?
Peripheral artery disease (PAD) is a cardiovascular disease which mainly affects the arteries that carry blood to the legs and feet It impacts more than 8.5 million American adults.1 In PAD, arteries are narrowed and made less elastic by changes in the artery walls.
PAD is caused by “atherosclerosis,” which refers to a buildup called “plaque,” made up of cholesterol, fatty substances, calcium and fibrin (protein involved in the clotting of blood). This buildup reduces blood flow through the arteries and can lead to pain and lack of mobility. It is estimated that 12-14 percent of the general population is affected by PAD.
What is the Ranger DCB?
Ranger is a balloon catheter with drug applied to the balloon. Drug-coated balloons are inflated inside blood vessels to treat blockages and prevent re-narrowing while simultaneously delivering a therapeutic dose of drug to help keep the vessel open longer.
How is PAD treated with the Ranger DCB?
When treating patients with the Ranger DCB, a small puncture is made in the patient’s groin to gain access to the artery. A wire and catheter are inserted and moved to the narrowed section of the artery. When the physician is satisfied with the size of the lumen, the drug-coated balloon will be inserted. After the drug-coated balloon is inserted, it is inflated to make contact with the artery wall, allowing the drug to be released. The devices are removed and the puncture site in the patient’s groin is closed. The drug from the balloon is absorbed into the artery and is designed to help keep the artery open and prevent future narrowing of the artery.
What are the benefits of the Ranger DCB?
Ranger is a low dose DCB that is a proven safe and effective alternative to percutaneous transluminal angioplasty (PTA) with 12-month freedom from major adverse events (MAE) being 94.1% for those treated with the Ranger DCB versus 83.5% for standard PTA and 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. . Ranger’s proprietary TransPax™ coating enables efficient drug transfer. This helps minimizes drug loss in the bloodstream and has demonstrated to limit systemic drug exposure for the patient. The low-profile platform of the balloon also assists clinicians in performing streamlined procedures and navigating through challenging anatomy in order to deliver consistent therapy.
To learn more about the Ranger DCB, please visit http://www.bostonscientific.com/ranger