Senior Staff Writer
Medtronic plc doesn't "dabble in areas that are small," as CEO Omar Ishrak said at this week's Morgan Stanley's health care conference. And while Ishrak was not specifically referring to the Dublin-based company's peripheral business, it was a timely statement, given that its In.Pact Admiral drug-coated balloon (DCB) just became the first device of its kind to gain FDA approval to treat in-stent restenosis (ISR) in patients with peripheral artery disease (PAD), gaining a significant edge in the young-but-growing U.S. DCB market. ISR occurs in up to 40 percent of all stents placed in the superficial femoral artery, Medtronic noted.
DCB technology has been approved in Europe for several years, but the U.S. DCB market is still fairly young. Medtronic's In.Pact Admiral balloon was second to the U.S. market in December 2014, a mere two months after the FDA approved C. R. Bard's Lutonix 035 DCB in October 2014. A third competitor – Spectranetics Corp. – is coming in hot, however, with its highly-anticipated Stellarex DCB expected to hit the U.S. market in late 2017, fueled by strong 12-month data in Europe. Boston Scientific Corp. may be fourth in line, if it decides to pursue FDA approval for its Ranger DCB. That would make Boston Scientific Corp. the only player in the space that can also offer peripheral drug-eluting stents (Eluvia).
Rick Wise, of Stifel, issued a report earlier this week projecting that the worldwide DCB market will approach $800 million by 2020, with additional indications (including ISR) adding an incremental $200 million to that estimate.
Medtronic's Admiral balloon was initially approved for superficial femoral and popliteal arteries, and in July the FDA also approved the device in longer, 150 mm lengths, to extend treatment options for long lesions in patients with PAD. FDA approval for the ISR indication was based on data from the company's global IN.PACT study, which compared the treatment to a standard percutaneous balloon angioplasty.
"We are experiencing a paradigm shift in treating patients with complex PAD," said John Laird, interventional cardiologist at U.C. Davis Medical Center and co-principal investigator for the IN.PACT SFA trial.
Treatment options for this patient population were previously limited, Laird said. Doctors were challenged to find a durable treatment for PAD patients, considering the complexity of the disease, added Mark Pacyna, vice president and general manager of Medtronic's peripheral business, which is part of the company's aortic and peripheral vascular division. According to Pacyna, the IN.PACT global study was designed to look at challenging lesions in real-world patients and, so far, the device has demonstrated consistent outcomes across all patient morphologies. One-year primary patency rate in the IN.PACT global ISR imaging cohort was 88.7 percent, and the clinically-driven target revascularization (CD-TLR) rate was 7.3 percent. The mean length of lesions was 17.2 ± 10.5 cm, with 34.0 percent occluded ISR lesions.
Medtronic has benefited this year from a number of clinical data presentations showcasing the safety and efficacy of the Admiral DCB, which, according to Wells Fargo Securities LLC's Larry Biegelsen, has helped convert accounts and take share. The analyst also noted in a recent report that an FDA labeling change, which removes the need for pre-dilation and replaces it with adequate vessel preparation. The company is the only U.S. competitor that sells both atherectomy and DCB products, and Biegelsen estimated that Medtronic finished the first quarter of the current calendar year with roughly 54 percent of the DCB market, leaving Bard with 46 percent.
Competition heats up
As the first company to tap the U.S. market with a drug-coated balloon, Bard, of Murray Hill, N.J., still appears to have a few tricks up its sleeve to stay competitive. During its analyst day in May, Bard highlighted a lineup of anticipated milestones to extend the reach of the Lutonix platform, including the U.S. and Japan launch of a below-the-knee Lutonix DCB sometime in the second half of 2019, and the Lutonix China launch sometime that year for the SFA (above-the-knee) indication. But even sooner than that, the company is expected to get approval for long lesions (up to 300 mm) by the end of this year.
Lutonix continues to perform well in the market, and Biegelsen noted in late July that global Lutonix sales rose by about $2 million to more than $33 million in the second quarter.
"Management believes that the company is sharing the market with competitor [Medtronic]," Biegelsen said.
The FDA also recently allowed Bard's one-year registry data to be added to the Lutonix label and gave the company permission to promote it, which Biegelsen said should enhance the device's position against Medtronic's Admiral.
But the device that really seems to be grabbing analysts' attention is the Spectrantics Stellarex. In August the company shared 12-month data from a European randomized clinical trial of the balloon at a symposium in Chicago that proved the device has what it takes to compete with the likes of Lutonix and Admiral. (See Medical Device Daily, Aug. 12, 2016.)
The next big value-unlocking catalyst is expected in late October or early November when the Stellarex U.S. trial data is presented at TCT.
"We see Stellarex driving a dramatic positive sales growth inflection as well as first-time EBITDA profitability in 2018," Wise said in a note this week.
The analyst projects Stellarex will take roughly 18 percent of the worldwide market share by 2020. Given the growing body of "highly positive" clinical data, however, particularly compared to Bard's Lutonix, Wise added that the share projection could prove conservative, with at least mid-20s share possible.
Not all are betting on DBS
In a mid-July report following a clinician due diligence panel that Stifel hosted, Wise reported that at least one high-volume vascular surgeon panelist is not quite sold on the current DCB technology. The clinician, who averages about 500 cath lab cases a year and a couple hundred or so open surgery cases for PAD, does not even use the new balloons in his practice, Wise said.
"In his view, there is not enough clinical benefit to justify the incremental cost associated with DCBs. This clinician believes DCBs show little value relative to other interventions in claudicants (basic disease) and becomes cost prohibitive in longer, complex lesions," Wise noted. "Interestingly, the surgeon suggested that if one looked at published DCB quality of life data – namely walking distance – one does not see a meaningful difference in control vs. treatment group, suggesting little actual clinical DCB benefit."
Looking ahead, the vascular surgeon is most interested in a bioresrobable drug eluting peripheral stent as a potential "home-run" type intervention for broad SFA disease, Wise said. On ISR cases, the doctor uses Spectranetic's laser atherectomy system. However, for de novo lesions, broadly, the surgeon does not believe current data (or his clinical experience) justify atherectomy as a standalone treatment option, the analyst added.