Medtronic ($MDT) has submitted final data to the FDA for its drug-eluting balloon. The move comes ahead of the first agency panel review of a drug-eluting balloon from competitor C.R. Bard ($BCR) on June 12. Medtronic hopes to get an FDA approval for its balloon around May or June 2015 and to get it onto the U.S. market about a year later.
The company highlighted expectations for its drug-eluting balloon during a June 5 meeting with Wall Street analysts and investors. It anticipates that its IN.PACT Admiral drug-coated balloon will be the cornerstone to building a peripheral franchise.
Medtronic sees the drug-eluting market as potentially worth $600 million by fiscal year 2018, the company's EVP and Cardiac & Vascular Group President Michael Coyle said at a recent analyst event. Medtronic's fiscal year closes at the end of April.
"We think this will be an area where we will have a lead and retain a lead, and will be one of the fastest-growing growth drivers that we have. It also now gives us that anchor store, around which to build a broader peripheral franchise," Coyle said of the drug-eluting balloon. He added that an approval for the IN.PACT Admiral could come in early fiscal 2015.
Drug-eluting balloons rank among the major future growth drivers for Medtronic. "Whether we talk about predictive diagnostics in the low-power segment of CRM, the AF business, renal denervation, transcatheter valves, the drug-coated balloons and peripheral, these are fundamental new growth opportunities where prior-year comparisons will allow very significant growth to be demonstrated," Coyle said at the analyst meeting.
Medtronic expects to be at the front of the pack in drug-eluting balloons; although at this stage it's among a field of competitors developing them without any yet approved by the FDA.
Coyle is effusive about the data thus far. "What we found was that relatively, compared to drug-eluting stents or standard stents, the results were much better; best-in-class efficacy whether we look at the rates of closure or re-closure or re-intervention," he said. "When you look at 6 months versus competitive balloon products or drug-coated products or 12 months against stents and drug-eluting stents, the performance on both that of PAC and re-intervention was significantly better than anything that anyone else has shown."
In the pivotal data after 12 months, primary patency rates were 82.2% for the drug-coated balloon (DCB) patients versus 66.8% for the percutaneous transluminal angioplasty (PTA) patients. In addition, lesion revascularization rates were 2.4% for DCB patients and 20.6% for PTA patients. The trial was in patients with peripheral artery disease in the superficial femoral artery (SFA) or proximal popliteal artery (both located in the leg above the knee).
About 450,000 U.S. patients undergo interventional procedures annually for peripheral artery disease in the superficial femoral artery (SFA), the most common form of the condition, according to the company. The SFA runs along the leg from groin to knee and is close to the surface, making this a challenging location for the use of stents.
An estimated 8 million to 12 million U.S. patients have peripheral artery disease, estimates Medtronic. This is characterized by the accumulation of fatty deposits in the arteries that carry blood to the extremities. In the legs, this condition can cause severe pain in the calf muscles. A more serious form of the disease is critical limb ischemia, which also includes ulcers or gangrene that can lead to limb loss or even death.
Medtronic's DCB received a CE mark in Europe in 2009. The product has been studies in more than 4,200 patients in at least 24 studies worldwide.
- here is the press release on the final data submission by Medtronic to FDA