A tool like a tiny orbital sander is the heart of the Diamondback 360° system, a medical device that removes plaque from the walls of arteries in the leg. It’s the flagship product of Cardiovascular Systems, a St. Paul–based medical device company focused on developing and commercializing interventional treatment systems for vascular disease.
On one end of the orbital sander—a flexible drive shaft that resembles a very thin catheter—is a “crown” coated with diamond grit. When the device is turned on, the crown, which is not centered on the shaft, spins. As the sander orbits around the vessel wall, the grit sands away hardened plaque, creating a smooth channel in the vessel.
“The diamond-coated crown takes the plaque off the arterial wall while leaving the healthy wall tissue alone—not unlike shaving, when healthy skin moves away from very sharp razor blades as they cut the whiskers,” says Dave Martin, president and CEO of Cardiovascular Systems.
The Diamondback 360° was granted FDA approval in August 2007. According to the company, it’s the first device that can routinely treat a patient’s circulation problems below the knee, which can lead to a potentially fatal condition known as peripheral arterial disease, or PAD.
“At this early stage of commercialization, our biggest competitor is awareness,” Martin says. “The number of patients diagnosed with poor circulation and not treated is much greater than the number treated each year. An untreated patient may develop pain and discomfort, which can eventually lead to infection, limb loss, and sometimes death. We can restore blood flow to relieve pain and heal those wounds, which keeps people walking and heads off amputation. Up to 180,000 amputations are done in the U.S. every year as a result of PAD.”
According to Martin, more than 18,000 patients have been treated with Cardiovascular Systems’ devices in more than 600 hospitals in the United States. “However, there are nearly 2,000 hospitals that treat PAD patients who can benefit from the device,” he says. “That’s the urgency—to drive adoption in those hospitals to save more legs. As many as 12 million Americans suffer from PAD, and the number is growing with age, obesity, and diabetes all on the rise.”
The origins of Cardiovascular Systems date to 1989, when Dr. Leonid Shturman, a physician and inventor, incorporated the company to develop several technologies. In 1997, Shturman began focusing on the development of the Diamondback 360°, advancing the concept through prototypes and initial animal studies.
Needing clinical and regulatory expertise to guide the product through the FDA approval process, the company named Michael Kallok, a medical industry veteran, president and CEO in 2002, and Shturman left the company he had founded. Martin, a board member since 2006, assumed leadership of the company in February 2007 to oversee commercialization of the Diamondback 360° and the company’s growth.
Cardiovascular Systems went public in February through a creative reverse merger after unfavorable market conditions derailed a planned IPO in 2008. Cardiovascular Systems then acquired Colorado-based biopharmaceutical company Replidyne. Before the merger, Replidyne’s operations were terminated when the FDA did not approve a drug it was trying to market for the treatment of respiratory and skin infections. The all-stock transaction generated about $37 million.
“Completing the reverse merger in the teeth of financial market chaos while executing an aggressive commercial ramp was a tremendous accomplishment by the entire Cardiovascular Systems team,” Martin notes. The company trades on Nasdaq under the symbol CSII.
Cardiovascular Systems’ revenues in the quarter ending in June 2009 totaled $15.7 million, and Martin expects the company to reach profitability by mid-2011. “It’s a statement to the team and the plan that even with financial market chaos and zero IPO opportunity, we still were able to put on an aggressive ramp and installation in our early stages,” Martin says.
Educating the physicians who will be using the device is part of the challenge. “We train the specialists—the cardiologists, the vascular surgeons, and the interventional radiologists,” Martin says. “But all three are largely dependent on primary care physicians, internists, and podiatrists who need to be aware of the procedure and refer their patients for treatment. It’s a big task. Some literature says that it takes seven years for a new technology or drug to be introduced and then become the standard of care. We’d really like to accelerate that.”