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| C.R. Bard's Lutonix Drug Coated Balloon |
C.R. Bard's ($BCR) senior vice president of science technology and clinical affairs, John DeFord, expounded on a just-published study in the New England Journal of Medicine, which showed that its Lutonix drug-coated angioplasty balloon for peripheral artery disease has superior efficacy and equivalent safety to standard angioplasty balloons.
In addition to physically disrupting the plaque blocking blood vessels, Lutonix delivers the common antiproliferative drug paclitaxel in an attempt to prevent restenosis, or the renarrowing of the arteries in the months and years following treatment. It's locked in fierce competition with Medtronic's ($MDT) similar In.Pact Admiral drug-coated balloon in the nascent U.S. market; Bard's device received FDA approval in October and Medtronic's in January.
DeFord said the 476-patient study is the largest randomized, controlled trial conducted on drug-coated angioplasty balloons for PAD. Nearly two-thirds (65.2%) of Lutonix patients met clinical endpoint of primary patency at 12 months, compared to just over half (52.6%) of patients who received a standard nondrug-coated angioplasty balloon.
To successfully meet the endpoint 12 months after implantation, the patient had to be free from intervention at the site of initial treatment and the treated vessel had to be at least 50% open. DeFord said a vessel that is less than 30% open poses clinical challenges.
Changing the patients' overall quality of life is difficult, DeFord said, because as indicated by the trial, PAD patients often suffer from other complications, such as diabetes or heart disease. Still, patients who received Lutonix demonstrated improvements in the Rutherford quality of life index compared to those in the treatment arm as well as improved patient-reported walking distance scores, DeFord said.
The Lutonix had a similar safety profile to standard angioplasty balloons, as measured by metrics like the rates of death (2.4%), amputation (0%) and thrombosis (the formation of a blood clot) requiring reintervention (.4%).
Despite the good news overall, the study did not find a statistically significant difference in target-lesion revascularization at 12 months, meaning the rate of repeat procedures at the site of the initial lesion was similar in both the control (16.8%) and treatment arm (12.3%).
DeFord said the result was due to the low overall rate of revascularization, which resulted in a small sample size, and was confident a larger trial would have detected a statistically significant difference in the metric due to the clear difference in the rate of restenosis among the two arms.
He said the trial had some unique features designed to reduce bias, including the exclusion of patients who had a previously existing peripheral stent (typically 20-30% of patients who use the device in commercial settings), as well as an extensive blinding procedure to keep physicians from making reintervention decisions based on whether the patient had received angioplasty with the drug-coated Lutonix or a standard balloon.
The study should increase confidence in the Lutonix, which the company has said is exceeding sales expectations (though it hasn't yet revealed a specific number).
Meanwhile, DeFord said C.R. Bard is enrolling patients in clinical trials to convince the FDA to expand the indication of the device to include use to treat in-stent restenosis (or recurrent narrowing at the site of a peripheral stent), PAD below the knee (about 30% of all cases), and PAD in hemodialysis patients.
The company is considering starting trials to bring its European Lutonix drug-coated balloon for use in the coronary arteries to the U.S, DeFord said. He explained that the market for such a device is quite small, since it would be used in only the 10% of coronary stent patients who experience restenosis.
Lutonix (and Medtronic's In.Pact Admiral) received Medicare bonus reimbursement for use in outpatients in February, and the payments were made more generous in June. DeFord said Bard expects to receive bonus payments for use on the inpatient side in October.
In February, Bard teamed up with Boston Scientific ($BSX) to jointly sell and distribute the Lutonix. DeFord said the alliance makes sense for Bard because Medtronic's sales force is quite large, especially now that it has acquired Covidien.
- read the release
Special Report: FierceDrugDelivery's 10 biggest partnerships in drug delivery-Boston Scientific- C.R. Bard
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