By Larry Haimovitch

Medical Device Daily Contributing Writer

September 28, 2016

LAS VEGAS — The headline in a recent supplement to Endovascular Today stated trumpeted that “Drug Coated Balloons Come of Age.” This statement perhaps best captures what was a very informative annual Vascular Interventional Advances (VIVA) meeting, which took place here last week.

At an analyst meeting here, Medtronic (Dublin, Ireland) management noted that the global DCB market approximates $220 million today and projects that it will grow at a 50% CAGR in the next four years. Thus by 2020 the global DCB market should reach or exceed $800 million. The company believes that it is the DCB market leader, with a greater than 50% market share.

Two of Medtronic’s key trials--the In.Pact SFA trial and the In.Pact Global Clinical Study--demonstrated outstanding safety and efficacy.

These studies, which addressed patients with symptomatic above the knee femoral popliteal (fem-pop) disease, showed a huge benefit for Medtronic’s DCB versus the “plain old balloon angioplasty” (POBA) control group. Specifically, primary patency was 69.5% for the DCB vs. 45.1% for POBA, while clinically-driven target lesion revascularization was vastly better at 15.2% vs. 31.1%.

Most notably, this trial is is the first ever to demonstrate a durable treatment effect for three years. In a packed room, the presenter Prakash Krishnan, MD, stated that “these data support this device as a first line therapy for patients with symptomatic femoral popliteal disease.” He further commented that DCBs now represent “a paradigm shift in how we manage symptomatic fem-pop disease.” This positive DCB commentary was echoed many times throughout the VIVA sessions.

The In.Pact Global Clinical Study, which treated over 1400 patients in 64 sites worldwide with treatment of symptomatic fem-pop disease, also showed marked superiority. According to the presenter Michael Jaff, OD, “this is the largest clinical evaluation of real world patients treated with DCBs to date and shows unequivocal benefit in a real world setting.”

Meanwhile, C.R. Bard (Murray Hill, New Jersey), which was the first company to attain a U.S. DCB approval (October 2011, three months earlier than Medtronic) reported that the 24 month results in its 527 patient real world registry showed solid results. In particular, results were impressive in the challenging 106-patient long lesions subgroup. The company disclosed that it has a PMA supplement application for long lesions currently under FDA review.

Bard is solidly in the lead for below the knee (BTK) DCB sector, with a possible approval in 1H-2018. The  company estimates a $350 million worldwide BTK market opportunity.

Boston Scientific (BSC; Marlborough, Massachusetts) is also a DCB competitor, having attained CE Mark with its Ranger brand in 2014. At an analyst meeting here, management indicated that it was hopes to commence its pivotal U.S. DCB trial in late 4Q-2016 or in 1Q-2017. This timetable suggests that it could reach the domestic market sometime in 2020. It also commented that its gradually withdrawing from its DCB marketing agreement with Bard but it did not disclose any details.

BSC’s management estimated that the global peripheral vascular (PV) market is about $4.5 billion and believes that its Peripheral Intervention division has the number one position with approximately $1 billion in sales. Moreover, this division grew at 13% in 2015 and 14% in 1H-2016, much faster than the overall 4%-6% for the entire PV market.

Its strategy is to compete not only with DCBs but also with drug-eluting stents (DES). The company believes that both DCBs and DES have important roles to play in the management of PV leg disease and views them as highly complimentary.

BSC received the CE Mark for its Eluvia drug eluting stent in February, based on the one-year results of its MAJESTIC trial. The two-year follow-up trial, which was reported here, treated some challenging patients and showed superb results. The presenter Stefan Muller-Hulsbeck, MD, concluded his Late Breaking session talk by saying that “patients sustained a high degree of clinical improvement, with a good safety profile and low intervention rate at 24 months.”

The company began enrolling patients in its large IMPERIAL DES Eluvia trial in 4Q-2015. The study will include approximately 485 patients in 75 sites worldwide and will be used to obtain U.S. and Asian approvals.

Another key DCB player is Spectranetics (Colorado Springs, Colorado), whose Stellarex device is believed by many industry pundits to be the most efficacious DCB yet. It has gained a CE Mark and numerous clinical studies to date (6000 patients have been enrolled in six different trials) have demonstrated its outstanding efficacy and safety. A key milestone will be the results of the ILLUMENATE U.S. pivotal trial, which will be delivered at a Late Breaking Clinical Trial session at TCT on November 2. If these results are as good as earlier studies, it is likely that Spectranetics will gain FDA approval within the next 12 months.

In other DCB news, Singapore-based QT Vascular Ltd. recently received an FDA conditional IDE approval to begin enrolling patients in the pivotal study of its Chocolate Touch DCB trial. This product achieved CE Mark in July 2015.

This trial will enroll patients with superficial fem-pop disease and will be randomized 1:1 to the Bard Lutonix DCB. To our knowledge, this is the first DCB trial comparing one DCB to another, which may be more telling because it will be an “apples to apples” study. All previous trials have randomized patients to POBA and have different patient inclusion/exclusion criteria. Thus head to head comparison of their results is virtually impossible.

Privately-owned, venture capital-backed Shockwave Medical (Fremont, California) enjoyed positive news with the disclosure of the results of its DISRUPT PAD trial.

Six month follow-up data from the single arm, two phase multi-center, 95 patient trial, which treated calcified femoral-popliteal lesions of up to 15 cms were very favorable, with excellent safety and efficacy seen across all patient subgroups. Specifically, there was 100% procedural success with a low residual restenosis rate of 24% and an acute gain of 3mm. In his presentation, Thomas Zeller, MD, stated that “these results are compelling and this approach could become a significant competitor to other atherectomy approaches.”

At the Medtronic analyst meeting, Mark Pacyna, general manager and vice president of its Peripheral Vascular division noted that “calcium remains a major issue and challenge . . . it is still a frontier that we have not effectively solved.”

Shockwave has developed a proprietary lithoplasty technology, which uses the intermittent sound waves of lithotripsy to disrupt both superficial and deep calcium while minimizing soft tissue injury. In conjunction with the calcium disrupting power of lithotripsy, it features the familiarity and simplicity of a traditional balloon catheter platform to dilate the lesions following calcium disruption and restore blood flow.

This device attained CE Mark in January 2015 and several days before VIVA received FDA approval. Shockwave plans a limited U.S. commercial release of its Lithoplasty System in 2017 and will initiate a global randomized trial to gather further clinical data on the benefits of Lithoplasty treatment.

A novel endovascular approach to arteriovenous fistulas (AVFs) was presented in a late Breaking Clinical Trial session here by Charmaine Lok, MD of University Health Network (Toronto, Canada). The goal of the study was to compare the results of an endovascular approach to AVF (endo AVF) creation versus the traditional surgical AVF (sAVF) route.

AVFs are considered to be the “gold standard” for creating kidney dialysis vascular access. They typically are performed using traditional surgery techniques but they are suboptimal because of (1) their high failure rates; (2) they often require post-creation interventions to facilitate the maturation of the fistula. The failure rate, depending on which study is cited, ranges from 20% to 60% and the average intervention ranges between two and three.

This prospective non-randomized trial, dubbed Novel Endovascular Access Trial (NEAT) enrolled a total of 80 patients in Canada, New Zealand and Australia with 12 months follow-up. EndoAVF achieved several notable benefits, including a 98% procedural success, a very low complication rate of 8.3%, a 91% fistula maturation rate and an impressive 0.6 per patient year intervention rate. Overall, there was six-fold reduction in interventions in the endo arm versus the traditional surgical arm. Importantly, Dr. Lok also noted that endoAVF is associated with less cost (estimated $11,000 savings) compared to the matched sAVF cohort.

She concluded her talk with the comments that “NEAT demonstrates that this is a promising technology for facilitating AV fistula creation for pre-dialysis and dialysis patients.”

During a Q & A period following Dr. Lok’s presentation, the moderator Dr. Michael Jaff, said that “this is fascinating data and a very promising technology for dealing with a huge problem.”

Privately-owned, venture capital-backed TVA Medical (Austin, Texas) is the developer of this novel system, which is called the everlinQ endoAVF System. In the procedure, two thin flexible magnetic catheters are inserted into an artery and vein in the arm. A small amount of radiofrequency energy is used to connect the artery and vein to create the fistula, and the catheters are removed.

TVA attained a CE Mark in 2014 and is currently in discussions with the FDA regarding US market clearance. When approved, the device will enter a large market with an estimated 3 million patients worldwide (450K alone in the U.S.) that suffer from problems related to vascular access that is needed for hemodialysis.

VIVA 2016 Conference

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