Bard’s Balloon Catheter Takes PAD Treatment To New Heights

Clinicians treating peripheral artery disease (PAD), a condition that the American Heart Association says affects some eight million US individuals, can use CR Bard Inc.’s FDA-approved Lutonix 035 drug-coated balloon with even greater confidence, in the wake of newly published research findings.

So says John A. DeFord, PhD, Bard's senior vice-president, science, technology, and clinical affairs, who spoke to IN VIVO after the release of LEVANT 2 study data in the June 25th online issue of the New England Journal of Medicine (NEJM). The study’s findings showed the superior primary patency of the paclitaxel-coated Lutonix DCB over standard PTA, and showed safety consistent with standard PTA balloons.

“What we’re seeing in real-world registry is that 91% of patients have primary patency at one year [i.e., the vessel stays open without the requirement for any additional treatment], and 92% of patients didn’t need an additional treatment in a year," DeFord said. He added, “Those are fantastic results.” He said that while there is a learning curve for physicians who may not be used to a technology like this, the results are improving as users become more familiar with it.

For Bard the case is compelling. “To be able to leave nothing behind but a little bit of the drug and to get similar results as with a drug-coated stent is a huge advantage for the patient,” DeFord continued. Permanent implants can limit the options of patients in cases of restenosis, which is very difficult to treat if the vessel grows around it.

Lutonix 035 DCB is designed to decrease the incidence of restenosis and improve patency in patients with stenosed femoropopliteal vessels, often seen with PAD. It is coated with a therapeutic dose of the drug paclitaxel, and also utilizes standard mechanical dilatation of the vessel to restore blood flow for patients with PAD in the femoropopliteal arteries.

More than half of US incidence of PAD involves the superficial femoral artery (SFA) and popliteal arteries. Globally, nearly 202 million patients suffer from this disease, which if untreated could increase the risk of heart attack or lead to death.

Severe cases of PAD can lead to amputation of the affected limb, causing huge physical and psychological burdens to patients and significant costs to the health care system. Use of Lutonix can improve patients’ QoL. The NEJM article referred to the Rutherford score (a clinical staging system for describing PAD) improving and staying improved over a period of a year without re-intervention.

The secondary benefit, said DeFord, is that the Lutonix system results in lower costs to the health care system, as fewer patients have to come back for re-interventions. He said, “Once you’ve got a stent, you’re destined to have another stent, or to need bypass surgery, which is much more extreme.” Ultimately, a worst case scenario is amputation, while the Lutonix 035 DCB can reduce the re-intervention rate.

Cleared by the FDA in October 2014, the product and system are used in most US hospitals that have a cath lab and can do peripheral procedures. That means that well over 2,000 US hospitals have access to this technology.

Additionally, studies are ongoing in Japan, China, Korea, and throughout Europe, where the Lutonix 035 DCB is CE-marked. Latin America is also being evaluated by Bard. This equates to a lot of expansion activity for the technology worldwide. Incidence of PAD can be a little different from population to population, based on diet and genetics, but the etiology of the disease itself is very similar. Anatomies can be slightly different in Asian countries, and there is a lot of smoking in Asia, which is one of the principal causes of PAD.

Boston Scientific Deal “Makes Sense”

Earlier this year, Boston Scientific Corp. signed a deal to distribute Lutonix in the US under a limited distribution agreement that is designed to expand the reach of the product. [See Deal]

Lutonix 035 DCB was the first drug-coated balloon approved by the US FDA, in October 2014 (following a 9 to 0 vote on each element of safety, efficacy, and benefit/risk by the FDA’s Circulatory Systems Devices Advisory Panel), but Bard latterly has had competition from Medtronic PLC’s DCB, the Impact Admiral.

Given that Bard’s peripheral sales force is much smaller than that of Medtronic, and that Boston has a big presence in the peripheral space, it made sense to set up a dedicated, restricted deal with its Marlborough, MA, rival. Bard is now on an equal footing with Medtronic in this business area. Boston’s view, as expressed by its president of peripheral Interventions, Jeff Mirviss, is that “Lutonix DCB is a great addition to our broad portfolio of vascular products."

Bard divested its electrophysiology business to Boston a couple of years ago, but DeFord acknowledged that Bard has not done anything like the Boston deal in recent memory. He said, “We know their management team well and have a good working relationship. We remain in competition, but in places where it makes sense to work together, we try to do so.”

Whether similar marketing deals might be set up to penetrate the OUS DCB markets is an open question, although Bard has significant sales organizations in China, Korea, and Japan – countries that the group is particularly focused on for Lutonix.

Full US Reimbursement – No Device Offset

In the US, Lutonix is covered by CMS for use in the outpatient setting. This is where 70% of PAD cases are treated, and the situation is similar in Europe. CMS updates its inpatient reimbursement payments every October, and as Bard received FDA approval in mid-October 2014, it missed last year’s round. But the outlook is good for receipt of inpatient reimbursement this fall.

In the outpatient decision, fairly unprecedentedly CMS decided that it would not apply the device offset, and would instead give full reimbursement for the DCB. Fewer than 20 health care products have received such an approval since 2002.

In Lutonix’ case, CMS determined that costs associated with DCBs were not included in existing reimbursement for percutaneous transluminal angioplasty, stenting, or atherectomy procedures. Therefore, CMS removed this device offset charge from the calculation and will reimburse the full cost of DCBs in these procedures, with retroactive effect to April 1, 2015. “This speaks to the importance of a technology that can get top results that are seen in PAD, but not leave anything behind,” DeFord reiterated. Reimbursement is also available in some EU countries, including Germany.

Education The Key To Market Penetration

Drug-coated balloons are seen as a growing part of the treatment algorithm for PAD, and provide an alternative for physicians who choose not to place a permanent implant or scaffold. DeFord stressed that educating clinicians about Lutonix was a key element in the choice of therapy.

Medtronic’s Impact Admiral remains the only directly competing product so far in the US. It also uses paclitaxel, but has a different kind of excipient to Bard’s, and uses almost twice the drug, said DeFord. He added, “The coating on Lutonix adheres very well to the balloon until it’s in the vessel and releasing."

Lutonix is a major and “very impactful” product, but Bard launches 30 to 40 new products every year, and has “never been about one big product,” said DeFord. However, the balloon does serve as a good example of how Bard intends to shift the mix of its portfolio to faster revenue growth categories.

In the case of Lutonix, this process included first acquiring a “potential game-changing technology platform” (in 2011, via the purchase of the company Lutonix Inc., for $225 million, [See Deal] then investing in further development and clinical research, and ultimately becoming the first to US market in a new and fast-growing segment, Bard’s senior directors write in the group’s 2014 annual report.

Bard returns almost 8% of sales (fiscal 2014, $3.3 billion, +9%) to R&D and spreads this over its four primary business centers: general surgery, including hernia and soft tissue repair; oncology, including vascular access products; urology, including targeted body temperature management products, used for therapeutic hypothermia; and the vascular segment.

The group has some 15,000 products, including the recently launched first antibiotic-coated biologically derived hernia mesh, XenMatrix AB. "XenMatrix will also be an impactful product,” said DeFord.