UPDATED June 13, 2014, with comments from panel members.
The FDA’s Circulatory Systems advisory panel unanimously voted in favor of the Lutonix DCB, finding it safe & effective and ruling that its benefits outweigh its risks, although they did note data for effectiveness was not robust and that further study of the device’s effects on women is needed.
"In terms of the [effectiveness] outcome, is it statistically significant? Yes. And is it clinically relevant? I’m hearing from the panel that it is moderately or modestly clinically important, but if you’re in that group that’s benefiting, I think overall the committee is saying that this is a clinically relevant endpoint that’s met statistical significance," said panel chairman Dr. Richard Page of the University of Wisconsin School of Medicine & Public Health.
The Lutonix DCB is an over-the-wire percutaneous PTA catheter with a paclitaxel-based drug coating on the surface of the balloon. It is compatible with a 0.035" guidewire and has balloon sizes ranging from 4 mm to 6 mm in diameter and 40 mm to 100 mm in length and is available in 75 cm, 100 cm and 130 cm working lengths, according to FDA background materials released ahead of the meeting.
Peripheral arterial disease (PAD), or plaque build-up in non-coronary blood vessels, is estimated to be present in around 8 million people in the U.S., including 12-20% of those individuals older than age 60.3, the federal watchdog agency noted. It narrows arteries, compromises blood flow to lower extremities, causes leg pain and can lead to disability and amputation.
Current treatment options include use of PTA alone and other permanently placed drug eluting stents, but restenosis remains a general concern.
"I work in this area and there’s a great unmet need here, and I wish the efficacy and safety were a little more robust, but I voted yes, I do believe in the data," said Dr. Daniel Simon of New Jersey’s Vascular Access Center at West Orange.
Dr. Edwin Gravereaux, of Brigham and Women’s Hospital in Boston, agreed.
"It certainly proved to be as safe as balloon angioplasty, it possibly met the endpoint for mild improvement and I look forward to seeing what it can do in the future," Gravereaux said.
Lutonix was developed as device-drug combination that is not a permanent implant, but aims to reduce restenosis compared to PTA alone. If the FDA follows its panel’s recommendation, it would be the first non-permanent drug-device combination approved for treating new, or not previously stented, restenotic lesions in the U.S.
In terms of a post-approval study, the panel was unanimous that more patients need to be collected for a minimum of 2 years; some panelists said they’d like to see a longer follow-up period.
"Specifically, we want to know more about longer-term in U.S. women, and we would really like to ideally understand the issue of the relationship to smoking. Some sort of relevant clinical endpoint would be nice, at least covered over the first couple of years," Page explained.
Several panelists noted that Lutonix could also be useful for indications beyond those studied so far.
"I urge the sponsor to increase the robustness of the database by increasing the numbers in the registry and also to go onto areas like acute ischemia, et cetera, because I do think this is promising," noted Dr. John Somberg of Rush University Medical Center in North Carolina.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.