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| C.R. Bard's Lutonix Drug Coated Balloon |
C.R. Bard's ($BCR) Lutonix 035 Drug Coated Balloon Catheter became the first drug-coated balloon to receive PMA approval from the FDA on Oct. 10. It is indicated for the reopening of narrowed or blocked arteries in the knee or thigh in patients with peripheral artery disease (PAD).
"This is the first drug-coated balloon period for any indication," said Bard's senior vice president of science, technology and clinical affairs, John DeFord, in an interview. The company beat Medtronic ($MDT) in the race to approval. Unlike drug-eluting stents, drug-coated balloons are not implanted into the body permanently; instead the balloon is removed following the procedure.
Drug-delivering Lutonix is used in percutaneous transluminal angioplasty procedures. Following the partial opening of the diseased peripheral arteries using traditional, non-drug coated balloons, Lutonix is deployed to prevent renarrowing of the arteries after the procedure (restenosis).
"Peripheral artery disease can be quite serious. Preventing further blockage of arteries is just as important as removing the initial blockage," said Dr. William Maisel, chief scientist of the FDA's device arm, the Center for Devices and Radiological Health, in a statement.
"The clinical data show that Lutonix DCB may be more effective than traditional balloon angioplasty at helping to prevent further blockage in the artery," Maisel continued, referring to clinical trial results which found that 71.8% of Lutonix patients did not require additional treatment at 6 months, compared to 48.6% in the control group; another trial found that 65.2% of Lutonix patients did not have restenosis at 12 months, compared to 52.6% in the control group.
Lutonix is coated with the drug paclitaxel, along with the excipients sorbitol and polysorbate. The excipients aid in drug delivery and adherence to the balloon, DeFord said, adding that the coating's chemical formulation is unique to Bard.
There are 8 million people in the U.S. with PAD, and Lutonix is approved to treat 60% of them, DeFord said. Specifically, the product is approved for use in the thighs' superficial femoral arteries and the knees' popliteal arteries. DeFord said Bard is conducting clinical trials in the U.S. to expand Lutonix's indication for patients with PAD below the knee, in-stent restenosis, and hemodialysis patients requiring an arteriovenous access point.
The Lutonix 035 has been available for use in Europe since 2012. There are two other Lutonix drug-coated balloon catheters available outside the U.S., according to Bard's international product website, including one for coronary conditions. But DeFord said Bard hasn't decided whether to start trials to bring a Lutonix drug-coated balloon to the U.S. for heart conditions.
He's not overly concerned about physician training and adopting of the the Lutonix 035 in the U.S., saying the product is used similarly to other angioplasty balloons. It has a minimum inflation time of 30 seconds, he said.
Regarding reimbursement, DeFord said that Lutonix will receive payments in line with other percutaneous transluminal angioplasty devices, and is applying for additional bonus payments for inpatients and outpatients from the Centers for Medicare & Medicaid Services.
- read the company release
- read the FDA release
- here's the product's U.S. website