HAIMOVITCH MEDICAL

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EVAR market showing strong growth; new entrants enliven the competitive landscape


By Larry Haimovitch

Medical Device Daily Contributing Writer

October 18, 2013

LAS VEGAS — The thirteenth annual Vascular Interventional Advances (VIVA) meeting took place here last week. VIVA (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 has become increasingly popular over the past several years, fostered by an outstanding faculty and program, the beautiful venue of the classy Wynn Resort and the increasing recognition that less invasive, interventional techniques and technologies are becoming standard of care for treating many diseases and conditions.

One of the largest and more prominent global vascular device markets is endovascular abdominal aortic repair (EVAR), which garnered significant interest and attention at this meeting. The worldwide EVAR market is estimated by industry pundits at about $1.2 billion annually, with a growth rate in the high single digits. In the U.S., which is believed to be over half the global market, EVAR now has captured about 75% of the approximately 65,000 annual abdominal aortic aneurysm (AAA) procedures in the U.S. This represents a remarkable penetration of the AAA procedure market, given that EVAR devices became a  “standard of care” just several years ago.

In its embryonic years, the EVAR market was dominated by three large global firms, Medtronic (Minneapolis), WL Gore (Flagstaff, Arizona) and Cook Medical (Bloomington, Indiana) but competition has dramatically heated up in recent years. For example, Endologix (Irvine, California) has been gaining significant market share in the past few years, with its global revenue growth exceeding 25% annually. It currently accounts for about 10% of the global market and approximately 15% of the domestic market.

The EVAR market has attractive characteristics, that is, above average unit growth, high gross profit margins due to lucrative average selling prices ($12,000-$15,000 per device) and significant barriers to entry due to stiff regulatory demands around the world. However, two new and significant competitors have entered the U.S. market in the past year and they loom as potent players.

Privately-owned, venture capital-backed TriVascular (Santa Rosa, California) received a CE Mark in August 2010 and began its European commercial effort in January 2011, mainly focused on Germany and Italy. Following receipt of a PMA for its second generation Ovation Prime system in 4Q-2012, TriVascular began its U.S. marketimg and sales effort in early 2013.  It now markets this device in the U.S. with a direct sales force that is growing rapidly. To date, more than 2500 patients have been treated worldwide with this device.

The two year follow-up data from the Ovation Prime Global Pivotal Study was presented at a VIVA press conference and a Late Breaking Clinical Trials session last week. The results from 161 patients treated  at 28 U.S. sites and 8 offshore sites showed remarkable success, including no ruptures, no migrations, no conversion to open repair and 100% freedom from any endoleaks unrelated to the patient’s anatomy or the device itself.

At the VIVA press conference, Manish Mehta, MD, a vascular surgeon at the Albany Medical Center (Albany, New York)  discussed the many virtues of the Ovation device, notably its small profile (13-14 Fr.), its unique and highly effective sealing and fixation approach and its applicability to patients with challenging anatomies. He concluded saying that the two-year outcomes with the Ovation system are “promising and demonstrate excellent safety and efficacy, even in patients with challenging aortic neck and access.” As a result, he added that the “Ovation stent graft system may expand the patient population eligible for EVAR.” 

Responding to a question from MDD on the impact of a percutaneous approach (that is, a femoral artery stick, as opposed to a more invasive cutdown), which was used in 43% of the cases, Mehta noted that the average length of stay for this cohort was a mere one day. This represents a tremendous advantage for the hospital and third party payors, which saves money, and the patient, who experiences a much faster recovery and return to normal activityLyden reported on.

At a standing room only, TriVascular-sponsored luncheon symposium titled “Expanding EVAR: How a Truly Low Profile System with Novel Sealing Technology is Advancing EVAR,” several experts discussed the myriad benefits of the Ovation system.

Scott Lyden, MD, associate professor of vascular surgery at the Cleveland Clinic (Cleveland, Ohio) noted that the Ovation Prime system addresses a critical need in serving AAA patients with unusual anatomies that today are most often treated with AAA devices that are not expressly labeled for that indication. Lyden reported on a  Cleveland Clinic study of 100 explanted EVAR devices, which revealed that the major predictor of EVAR success is for patients treated with an “on label” device, whereas an implant outside of the label is the single biggest predictor of failure.

He concluded his talk by saying that the second generation Ovation Prime device expands on label eligibility because it is inclusive of patients who require a lower profile device who may also have a short neck.

“We saw excellent two-year outcomes in patients with anatomy not treatable by all other approved EVAR devices,” he noted.

The final luncheon speaker was Zvonimir Krajcer, MD, director of peripheral intervention at St. Luke’s Episcopal Hospital (Houston) who discussed in detail the benefits of a percutaneous vs. the more invasive cutdown procedure. He reported the following data:









Another recent domestic EVAR market entrant is publicly-traded Lombard Medical (Didcot, England), which received FDA approval for its Aorfix device in 1Q-2013 and began its domestic commercial efforts with a direct sales force in 3Q-2013. The company has been actively training U.S. physicians, with well over a hundred clinicians already trained in the U.S.

Aorfix was CE Mark approved in 2005 but the sales and marketing effort was severely hampered due to the lack of funds. The company has now raised significant funds and in addition to its direct efforts in the U.S., it also sells direct in both Germany and the UK.

This uniquely designed device is clearly differentiated by its slinky metallic ring, which promotes flexibility and enables it to be used in highly tortuous and high angle anatomy. Aorfix is the first and only device FDA-labeled EVAR product to treat neck angles of up to 90°, whereas none of its competitors are labeled to above 60°. In an interview with MDD, CEO Simon Hubbert said that the Aorfix addresses about 30% of the EVAR market that cannot be addressed “on label” by the competition. Hubbert also noted that there is increasing pressure on clinicians from the FDA to avoid off-label EVAR use, which he believes could buoy Aorfix’s market penetration.

There are several other, earlier stage EVAR devices that ultimately will represent technology upgrades and potential competition for the incumbents. One of the most intriguing new EVAR devices is the Nellix Endovascular Aneurysm Sealing (EVAS) system. Endologix acquired privately-owned Nellix in late-2010 and since that time, considerable effort has been expended to tweak the system for its ultimate commercialization.

The vast majority of current EVAR technologies use the same mechanisms for fixation and seal. Fixation is typically achieved by stent radial force, device columnar strength, hooks, barbs, and suprarenal stents and sealing is achieved by graft-wall apposition.

At a talk here titled “Polymer Based Stent Grafts” Andrew Holden, MD, an interventional radiologist and key EVAR opinion leader from Auckland Hospital (Auckland, New Zealand) estimated that current EVAR devices, used “on label,” are unable to treat as many as 40% of infrarenal AAAs. More importantly, Holden noted that a May 10, 2010 article titled “Endovascular versus Open Repair of Abdomiunal Aortic Aneurysm” in the venerable New England Journal of Medicine, found that long term EVAR durability was lacking. Specifically, an eight-year follow-up showed a 23% reintervention rate. Holden postulated that this disturbingly high rate is due to challenging anatomies, which results poor sealing and fixation, which in turn leads to aneurysmal leaking and device migration.

He noted that the fixation/sealing paradigm began to shift with the TriVascular Ovation, which treats the AAA by sealing the aneurysm using a constrained liquid polymer, which in a matter of several minutes polymerizes into solid material. Clearly, TriVascular’s approach has been vindicated by its outstanding clinical results.

Nellix’s EVAS is also polymer–based and its distinctive approach is that neutralizes the aneurysm from inside rather than outside the aneurysmal sac. Holden noted several theoretical advantages of this method, including procedural simplicity, the ability to treat anatomies difficult for standard EVAR, the likely reduction or elimination of endoleaks and device migration and finally, absence of secondary interventions with reduced surveillance requirements and cost savings.

The EVAS system received a CE Mark in February 2013 and the product has had a limited market release in Europe and New Zealand since then. Approximately 150 patients have been implanted to date.

A global EVAS registry will be initiated shortly and Endologix hopes to begin its U.S. IDE trial in the 1H-2014.

Another interesting and fledgling EVAR player is privately-owned, venture capital-backed Altura Medical (Menlo Park, California), which is developing a percutaneous, low-profile endovascular stent-graft designed to eliminate some of the major issues associated with conventional endograft procedure safety, efficacy and complexity. The company's plan is to provide a flexible, off-the-shelf, ultra-low profile device with an industry-first 12 French inside diameter. It also believes that it approach will significantly simplify the procedure.

CEO G. Ray Martin told MDD at VIVA that has performed about 20 cases outside the U.S. but it is still several years away from PMA and CE Mark approvals.

 

VIVA 2013 Conference

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