Physician interest in drug-coated balloons continues to increase

By Larry Haimovitch

Medical Device Daily Contributing Writer

November 15, 2014

LAS VEGAS — The 14th annual Vascular Interventional Advances (VIVA) meeting took place here last week. VIVA, based in San Jose, California is a not-for-profit physician organization dedicated to advancing the field of vascular medicine  and intervention through education and research. This meeting, which has clearly grown in stature over the past several years, is supported by an outstanding and diverse faculty, taking place at the classy Wynn Resort.

While this meeting covers a broad range of vascular interventional topics, it is safe to say that drug coated balloons (DCBs) were the hottest topic this year. That is not surprising, given that in early October, C.R. Bard (Murray Hill, New Jersey) became the first company to attain a U.S. approval for its DCB, which is branded as the Lutonix 035 DCB.

The approval followed quickly after a June 2014 meeting of the FDA’s Circulatory Systems Devices Advisory Panel had unanimously recommended its approval. Bard’s Peripheral Vascular sales force is already actively selling this device with the list price of $1900 each.

Bard’s entry into the DCB market was fostered by its late-2011 acquisition of privately-owned, venture capital-backed Lutonix (Minneapolis) for $225 million cash upfront, with an additional $100 million that was paid upon the PMA approval.

Bard’s LEVANT 2 global prospective randomized clinical trial had demonstrated improved patency for patients with peripheral arterial disease (PAD) in the superficial femoral artery (SFA). This LEVANT clinical program enrolled more than 1000 patients, showing excellent safety and efficacy compared to standard balloon angioplasty (PTA) .

Medtronic (Minneapolis) ia a virtual certainly to be the second entrant into the domestic DCB market. Its initial entry into the market occurred through its 2010 purchase of Invatec in 2010. The IN.PACT Admiral DCB is currently undergoing FDA review and medical device industry observers believe that it will gain final marketing clearance before the the end of this year or almost certainly in 1Q-2015. This device received the CE mark in 2009.

Data from the IN.PACT SFA I/II trial, which was presented here at a  late breaking clinical trial session, showed that PAD patients with diabetes achieved excellent results, with an 82.7% primary patency at 12 months versus 62.3% for the PTA group. The target lesion revascularization (TLR) rate was also stellar, with a 3.7% rate vs. 23.1% for the PTA group. TLR is widely considered to be a crucial endpoint--it accounts for repeat procedures due to recurrent symptoms related to the treated lesion.

Previously reported results for the entire cohort were outstanding, with an 89.8% primary patency rate at one year for DCB, versus 66.8% for the PTA group. Its TLR rate was also stellar, with a paltry 2.4% rate vs. 20.6% for the PTA group.

At a Medtronic sponsored lunch symposium titled “Refining Strategies for the SFA: A critical Look at Drug Coated Balloon Evidence,” presenters gushed about the potential benefit from DCBs.

Thomas Zeller, MD, the director of the Department of Angiology at Universitaets-Herzzentrum (Bad Krozingen, Germany) stated that Medtronic’s DCB represented “game changing technology,” adding, “the strong benefit of DCBs over PTA actually widens over time.”

At another Medtronic sponsored lunch, Christopher Owens, MD, associate professor of surgery, University of California San Francisco opined that “based on compelling data, DCBs should be considered as frontline therapy for treating SFA disease.”

At a Bard sponsored lunch, titled “Lutonix Drug Coated Balloon: 12 Month Results and Real World Experience,” Michael Lichtenberg, MD, Karolinen Hospital (Arnsberg, Germany) reviewed the 12 month outcomes from Bard’s global SFA registry. This trial will ultimately enroll 1000 patients at 75 sites around the world and will follow these patients for two years.

Dr. Lichtenberg reported on the 691 patients with one-year follow-up and noted that the patency rate has been superb at 89.3%, with excellent safety data as well. He stated that “ in the real world” DCBs perform much better than drug eluting stents and are now the “center of our approach” in treating SFA disease.

Just prior to the VIVA conference, Spectranetics (SPNC; Colorado Springs, Colorado) announced a definitive agreement to acquire the Stellarex DCB platform from Covidien (Dublin, Ireland) for $30 million. MDD’s sources report that there were several eager bidders for this asset. While SPNC was not the highest bidder, its nimble style in getting the deal completed expeditiously swayed Covidien to sell to SPNC.

This technology was originally developed by privately owned CV Ingenuity (Fremont, California), which Covidien acquired in January 2013 for an up-front cash payment of $100 million with additional contingent milestones of up to $170 million.

The transaction, which is subject to approval by the Federal Trade Commission and other regulatory agencies, as well as closure of the pending acquisition of Covidien by Medtronic, is expected to occur in early 2015.

Although this device clearly trails the Bard and Medtronic devices in a regulatory sense, lacking both the CE mark and FDA approval, there already is promising and robust human data.

The ILLUMENATE FIH Study, a prospective, multi-center, single-arm study was reported at the EuroPCR Scientific Congress in May. In this trial, 58 superficial lesions in 50 patients were pre-dilated with an uncoated angioplasty balloon, followed by treatment with the Stellarex DCB.

The study found the Stellarex DCB to be safe, with durable results to 24 months reported on 44 patients, including a primary patency of 89.5% at 12 months and 80.3% at 24 months. The TLR at 24 months was a very solid 85.8 percent.

In addition to the first-in-human ILLUMENATE trial, there are four active IDE trial in the U.S. and internationally. These include:

•ILLUMENATE Pharmacokinetic Study--to evaluate the drug levels in the blood; 25 patients to be enrolled at up to two sites

•ILLUMENATE Pivotal Trial--randomized trial to support the PMA in the United States; 360 patients to be enrolled at up to 45 sites

•ILLUMENATE European Randomized Trial--similar to the U.S. pivotal trial; 360 patients to be enrolled at up to 30 sites

•ILLUMENATE Global Registry--non-randomized; 500 patients to be enrolled at up to 65 sites

While regulatory approval timing is always difficult to predict, SPNC management anticipates that Stellarex will receive the CE mark approval in late-2014 or early-2015. U.S. commercialization is expected in the 2017 timeframe.

SPNC is clearly enthused about this transaction with its CEO Scott Drake saying that "drug coated balloons are and will be an integral part of the vascular landscape for many years to come. Global thought leaders believe that primary patency is the most important clinical metric, and Stellarex's feasibility data stands apart.”

At this juncture, it is challenging to predict which of the three companies will garner the most market share in the U.S. Bard has the major advantage of being “the first mover,” Medtronic will have a huge sales and marketing army to attack the market upon FDA approval and Spectranetics’s early data indicates it may have the most efficacious device.

Another challenge facing the uptake of DCBs in the U.S. is that they are priced at massive premium to standard PTA catheters. Specifically, Bard’s $1900 list price compares to a paltry $100 or so for traditional PTA catheters. This enormous price differential was a topic of discussion at the DCB sessions, where clinicians expressed concern about their practices or hospitals incurring significant financial losses because of the price differential of PTA vs. DCB.

According to informed industry sources, both Bard and Medtronic have already begun to address this issue, working to persuade Medicare that the tremendous benefits of DCBs warrants an “add-on” reimbursement code, which would offset the price premium.

VIVA 2014 Conference

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