SurModics (Eden Prairie, Minnesota) and Nexeon MedSystems (Charleston, West Virginia) have agreed to collaborate on the development of a new stent system for the treatment of renal artery disease. As part of a July 2007 agreement, the companies are already working together to develop a new stent system for coronary artery disease, which is now in clinical trials.

The stent system for renal arteries will incorporate SurModics' Finale Prohealing Coating technology and Nexeon's bare-metal Kodiak peripheral stent technology, the companies said. SurModics develops drug delivery and surface modification technologies and Nexeon makes devices for the treatment of cardiovascular and peripheral vascular disease.

SurModics also is an equity investor in Nexeon, the companies reported. Terms of the new agreement were not disclosed.

"The positive synergy between SurModics and Nexeon that led to the success of our coronary stent project made this second collaboration agreement an intuitive next step," said Mark Bates, MD, founder/CEO of Nexeon. According to the company, Bates has performed over 1,400 renal stent procedures and had the results of his renal stent series, the SOCRATES study, published in three medical journals over the last three years. "This renal stent coating collaboration underscores Nexeon's commitment to bringing innovative alternatives to patients with peripheral vascular disease."

Bates told Medical Device Daily that as a physician with a lot of experience with renal stent procedures he knows it is important to have a stent that is both strong and flexible, which can be hard to do, he says, "because the stronger you make the stent the stiffer it becomes."

Nexeon has developed a renal stent using a specialty metal and "unique" stent design, Bates said, that has a 25% smaller profile than the current market leader for renal stenting. The purpose of adding the coating from SurModics is to lower the risk of restenosis, he said.

Bates was unable to disclose a development timeline at this time.

"We are excited to further our collaboration with Nexeon MedSystems in our second joint development agreement," said Bruce Barclay, president/CEO of SurModics. "Nexeon has demonstrated a strong capability of developing products and rapidly advancing them into clinical trials. We are encouraged that Nexeon is extending its portfolio of products that leverages our Finale Prohealing technology beyond coronary stents into renal stents."

Atherosclerotic renal artery disease is the most common reversible cause of secondary hypertension, affecting more than 2.5 million people in the U.S., the companies noted. The condition can also cause atrophy of the affected kidney and even kidney failure.

Studies have shown that correction of renal artery stenosis with a stent can improve blood pressure and prevent further decline in renal function. This less invasive treatment has replaced renal bypass surgery at many institutions. However, one of the limitations of current renal stent technology is the potential for scar tissue to grow through the device and cause recalcitrant recurrence (restenosis), the companies said.

SurModics' Finale Prohealing Coating technology uses a thin layer of natural coating designed to promote rapid population of normal vessel-lining cells (endothelialization) rather than scar tissue, resulting in a healthy, functional artery, according to the company.

Nexeon says its Inversion Point technology is the foundation of its stent families. When applied to cobalt alloys, Inversion Point technology allows stents with dramatically lower profiles without sacrificing other important front-line stent characteristics such as radial strength, vessel coverage, and visibility, the company said.

Nexeon was known as Paragon Intellectual Properties until last October when it reported it had restructured, moving from a limited liability company with seven subsidiaries into a single corporation to form Nexeon. The company said the change was made to prepare for clinical trials and commercialization of its lead technologies. At the same time, the company also reported raising a $24 million round of financing to kick off PROTEX I, a first-in-man trial to evaluate its Protex coronary stent, which integrates Nexeon's low-profile (O.86 mm) cobalt alloy stent platform with SurModics' Finale prohealing extracellular matrix coating. SurModics was among the investors that participated in that round of financing (Medical Device Daily, Oct. 8, 2008). According to Nexeon, the Protex stent seeks to address late stent thrombosis while also aiming to reduce restenosis. Further, the stent system may eliminate the need for long-term antiplatelet therapy, thereby decreasing costs and reducing bleeding risks to the patient, the company noted.

Because Nexeon also has a renal stent platform, Bates said the companies felt it would be a "natural, positive transition" to apply SurModics' coating technology to Nexeon's renal application.

In October, when Bates spoke with MDD about Nexeon's formation, he emphasized that the company's products would be physician-driven with an end-user mindset. On Wednesday when he spoke to MDD about the company's newest agreement with SurModics, it was clear that those goals were still at the top of his list.

"I really feel like this is what you'll be seeing from us in the future is really different ways of looking at problems, different ways of responding to clinical needs," Bates said. And, he added, "When we enter the renal stent market we are going in to make a difference."

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