New Data Supports Orbital Atherectomy For PAD In “Real World” Population

Stealth 360 Orbital Atherectomy SystemCardiovascular Systems, Inc. unveiled new data from its CONFIRM study series in three poster presentations at the 2013 New Cardiovascular Horizons (NCVH) conference in New Orleans.

The CONFIRM study series evaluated the use of CSI’s orbital atherectomy system as a treatment for peripheral arterial disease (PAD)—in above- and below-the-knee lesions—in a real world population of patients (with no exclusions).


We’ve covered news from Cardiovascular Systems, Inc. before, most recently last November when it announced the completion of enrollment in its ORBIT II clinical trial in coronary arteries. Now a separate study, tagged CONFIRM, has yielded data relating to the company’s vascular offering, that has seen the light of day at a poster session at NCVH.

Setting the scene, 8 to 12 million Americans, most over age 65, suffer from Peripheral Artery Disease (PAD), which is caused by the accumulation of plaque in peripheral arteries (commonly the pelvis or leg) reducing blood flow. With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing faster than the rest of the population.

Among the therapeutic approaches used, balloon angioplasty and stents have significant shortcomings in treating hard, calcified lesions. Stents are prone to fractures and high recurrence rates, and treatment of hard, calcified lesions often leads to vessel damage and suboptimal results.

Orbital atherectomy devices include the Stealth 360° and Diamondback 360°, minimally invasive catheter systems developed and manufactured by CSI. These systems use a diamond-coated crown, attached to an orbiting shaft, which “sands away” plaque while preserving healthy vessel tissue, a critical factor in preventing reoccurrences.

The clever part of the device design is the way it avoids damage to the vessel walls. Once the “sander” has removed the hard calcium, the softer vessel wall will flex away from its eccentrically rotating sanding element. Furthermore, once the wall has been cleared of the majority of its calcium, it is then receptive to the use of balloon angioplasty.

The posters

Details of the studies  presented at NCVH can be found below. In the overall patient population, eighty-one percent of the lesions treated had severe or moderate calcification—historically considered a difficult patient population to treat. Patients studied included those suffering from renal disease, claudication (painful circulatory problems), and/or critical limb ischemia (CLI).

CSI posters include:

Dr. Michael Lee, UCLA Medical Center, Los Angeles, shared data from “Pooled Analysis of the CONFIRM Registries: Outcomes in Patients with Renal Disease Treated for Peripheral Arterial Disease with Orbital Atherectomy.” Results show that plaque modification with CSI’s orbital atherectomy system resulted in similar low procedural complication rates for patients with renal disease, compared to those without, despite having more unfavorable baseline clinical and lesion characteristics.

“Calcified lesions are difficult to treat, and patients with renal disease could have increased complications after peripheral intervention. These hard-to-treat patients have historically been excluded from clinical trials,” said Dr. Lee. “Treatment with CSI’s orbital atherectomy system resulted in low procedural complication rates, whether patients suffered from renal disease or not—indicating that orbital atherectomy is an effective tool for treating PAD, despite the severity of lesion characteristics.”

Orbital Atherectomy Outcomes of the Critical Limb Ischemia Patient Population within the CONFIRM Series,” by Dr. Tony Das, Cardiology and Interventional Vascular Associates, Dallas, Texas. Approximately 44 percent of patients in the CONFIRM series suffered from CLI, yet the occurrence of procedural complications was low after treatment with CSI’s orbital atherectomy system, regardless of arterial calcium burden.

Dr. George Adams, Rex Health Care, Raleigh, N.C., shared data from “Orbital Atherectomy Outcomes of the Claudicant Patient Population within the CONFIRM Series.” Claudicant patients represented 56 percent of patients in the CONFIRM study series, and of those patients, 81 percent had moderate to severely calcified lesions. Orbital atherectomy proved to be a safe tool for restoring blood flow in claudicant patients, regardless of the calcium severity.

“The majority of claudicant patients suffered from moderate-to-severe calcification, yet the occurrence of procedural complications was low after treatment with CSI’s orbital atherectomy system,” said Dr. Adams. “The favorable results demonstrate that orbital atherectomy can effectively treat PAD in claudicant patients, regardless of calcium burden.”

Source: Cardiovascular Systems, Inc., Business Wire