CD&D National Editor
CardioMind (Sunnyvale, California), an under-the-radar developer of coronary stents, has its eye on a specific, underserved sector of the drug-eluting stent (DES) sector: the worldwide market for vessel "scaffold" devices.
The company's first-in-human CARE II trial, which had its start "Down Under" at St. Vincent's Hospital (Melbourne, Australia), is analyzing the use of its Sparrow stent in small, difficult-to-treat blood vessels.
The cleverly-named Sparrow has a .014" crossing profile, some 70% smaller than in diameter than any approved stent currently on the market. Rather than riding to the site of the lesion over the guidewire, as is the case with every other stent, the CardioMind device travels within the guidewire lumen. It has, as President/CEO Charles Maroney told Cardiovascular Devices & Drugs, "a much smaller profile" than other stents on the market.
The mere fact that CardioMind has reported on its trial activity is news unto itself since it is one of those "stealth" companies that provides information to news outlets rather infrequently.
The CARE II trial, which in addition to Australia will enroll patients in Asia, Europe and South America. The randomized study eventually will enroll 220 patients, comparing three different stents: bare-metal and DES versions of the Sparrow, plus a competitive stent, the MicroDriver from Medtronic (Minneapolis), characterized by Maroney as that company's "bare-metal, small-vessel stent [which many interventionalists] feel is the best small-diameter stent" on the market today.
He said that the SynBiosys polymer that CardioMind has licensed from SurModics (Eden Prairie, Minnesota) "allows the Sparrow stent to gradually return to a bare-metal state, where we as an industry have 15 years of data showing no increase in late stent thrombosis."
The trial thus far has seen 12 patients implanted and has shown "very encouraging results," said Robert Whitbourn, MD, associate professor and director of the Cardiovascular Research Center at the Melbourne hospital. "I am impressed with the overall deliverability and performance of this new delivery system." He said the Sparrow system "opens up the possibilities of stenting in small vessels, branch vessels and other difficult-to-access vessels."
Whitbourn said such use "could ... expand the types of lesions in coronary artery disease that can be treated in more difficult patient populations." Maroney told CD&D that in these populations diabetics, for example, who tend to have smaller-diameter, more tortuous blood vessels in need of stenting the Sparrow is particularly useful.
"Our focus is in the smaller vessels. And smaller vessels demand more flexibility, the ability to access in tighter spaces." The combination, he said, "means that if you want to treat those smaller vessels, you need the most flexible, deliverable system available."
Maroney said that the data that will be collected in the CARE II trial will be used in getting the CE mark. "We're using a limus drug, sirolimus, that is generically available," he said, "[but], in the end, we're going to have to have a drug license to commercialize this product in the U.S. and overseas."