Feature | January 31, 2013

CONFIRM Study Highlights Effectiveness of Orbital Atherectomy in Treating PAD

With more than 3,100 patients and 4,700 lesions, study is largest atherectomy dataset ever for PAD

January 31, 2013 — Cardiovascular Systems Inc. (CSI) announced CONFIRM study series data presented at the 2013 International Symposium on Endovascular Therapy (ISET). Results show that CSI’s minimally invasive orbital atherectomy system is an effective treatment for peripheral arterial disease (PAD). CSI’s technology protects healthy vessel tissue while removing even the most difficult-to-treat plaque throughout the leg with fewer complications. The study, titled “Procedural Effectiveness of Orbital Technology in More Than 3,100 Patients with Infra-inguinal Disease: Results from the CONFIRM Series,” was part of a late-breaking presentation at ISET.

“The 3,000-plus real-world patients studied in the CONFIRM series shows that CSI’s orbital atherectomy system safely and effectively treats moderate-to-severely calcified lesions,” said presenter Tony Das, M.D., of Cardiology and Interventional Associates in Dallas. “Orbital atherectomy led to low bailout-stent usage, low adverse procedural-event rates and improved lesion compliance. Additionally, smaller randomized studies point to improved vessel durability and long-term outcomes — both of which are a first for atherectomy trials in the peripheral vascular space.”

The prevalence of arterial calcium is vastly underestimated in medicine today. Calcium, even if not visible through angiography, is present in about 65 percent of the 2.5 million people diagnosed annually with PAD. Moreover, calcium leads to poor outcomes and higher treatment costs when traditional balloon and stent therapies are used — including dissection, vessel wall trauma and stent fracture.

David L. Martin, CSI president and CEO, said, “CONFIRM reinforces the effectiveness of CSI’s orbital atherectomy in treating 'real world' patients. The dataset presented is the largest ever for PAD, and the CONFIRM study series shows consistent, repeatable results across numerous interventional physicians. CONFIRM gives physicians confidence that our technology is an effective and safe PAD treatment for patients.”

The CONFIRM series consisted of three studies that enrolled more than 3,100 patients with 4,700 lesions at 350 sites across the United States from 2009 to 2011. A majority of the lesions had moderate to severe calcium. During the initial study, physicians treated lesions to maximize the luminal gain, while the second and third study focused on removing calcium to change vessel compliance. Each study utilized a progressively smaller crown, which reduced slow flow, vessel closure and spasms.

Data shows that vessel preparation with CSI’s orbital atherectomy system enables low-pressure adjunctive balloon angioplasty across the studies, with low procedural events and bailout stents — which preserve treatment options in the future.

Overall Procedural Outcomes:

Per Lesion

 

 

CONFIRM I n=1,146

 

 

CONFIRM II n=1,734

 

 

CONFIRM III n=1,886

Mean Inflation

 

 

5.7 atms

 

 

5.4 atms

 

 

5.9 atms

Bailout Stent (due to dissections)

 

 

3.8%

 

 

5.8%

 

 

5.2%

Perforation

 

 

0.9%

 

 

0.6%

 

 

0.7%

Distal Embolization

 

 

n/a

 

 

2.2%

 

 

2.2%

Vessel Closure

 

 

2.1%

 

 

1.2%

 

 

1.4%

CALCIUM 360° Study 12-Month Results
Also presented at ISET was a study, titled “Comparison of Orbital Atherectomy Plus Balloon Angioplasty vs. Balloon Angioplasty Alone in Patients With Critical Limb Ischemia: Results of the CALCIUM 360 Randomized Pilot Trial,” by Jonathan Ellichman, M.D., of Southern Cardiovascular in Memphis, Tenn. Results demonstrated that orbital atherectomy treatment with low-pressure percutaneous transluminal angioplasty (PTA) safely restores flow in patients with critical limb ischemia and reduces major serious adverse events, compared to PTA alone.

At 12 months, CSI’s technology provided superior outcomes:

 

 

 

Orbital Atherectomy plus PTA

 

 

PTA alone

Mean Inflation

 

 

5.9 atms

 

 

9.4 atms

Dissections

 

 

3.4%

 

 

17.1%

Perforation

 

 

0%

 

 

2.8%

Distal Embolization

 

 

0%

 

 

2.8%

Bailout Stenting

 

 

6.9%

 

 

14.3%

Freedom from Major Serious Adverse Events

 

 

93.3%

 

 

57.9%

CALCIUM 360° is a prospective, multicenter, randomized study that compared treatment of below-the-knee lesions with orbital atherectomy versus PTA. All 50 patients had critical limb ischemia (CLI) and calcified lesions. These conditions are challenging to treat in the small arteries below the knees and often a precursor to amputation.

CSI Poster Session at ISET
Barry Weinstock, M.D., Mid-Florida Cardiology Specialists, Orlando, Fla., and Raymond Dattilo, M.D., (presenter), St. Francis Health Center, Topeka, Kan., presented “Cost Consequences of Orbital Atherectomy Plus Angioplasty vs. Angioplasty Alone for Treatment of Calcified Femoropopliteal Lesions” in a poster session at ISET.

Data showed that orbital atherectomy plus balloon angioplasty has a significantly lower average stenosis rate, exhibiting compelling short- and longer-term health and economic data for the use of atherectomy in the treatment of calcified femoropopliteal lesions.

For more information: www.csi360.com

Related Content

CT scans, cancer risk, radiation dose, Canadian study
News | Computed Tomography (CT)| June 27, 2016
June 27, 2016 — A new study in the Journal of Medical Imaging and Radiation Sciences surveyed doctors, radiologists a
News | Cardiac Diagnostics| June 24, 2016
Measuring antibody levels in the blood could be used to detect a person’s heart attack risk after researchers, part-...
Zoll LifeVest wearable defibrillator, WEARIT-II Registry results, CardioStim EuroPace 2016
News | Defibrillator Monitors| June 21, 2016
Zoll Medical Corp. announced that patients experience a high one-year survival rate following use of the LifeVest...
Sponsored Content | Videos | Structural Heart Occluders| June 16, 2016
This is an animation of how a Gore Cardioform Septal Occluder is implanted for the transcatheter closure of ASDs or P
News | Implantable Cardioverter Defibrillators (ICD)| June 14, 2016
Medtronic plc announced results from several feasibility studies evaluating a new approach to implantable cardioverter...
hypertrophic cardiomyopathy, HCM, strain echocardiography, risk assessment, ASE 2016
News | Cardiovascular Ultrasound| June 13, 2016
After following a large sub-set of patients, researchers found that by using strain echocardiography they could...
ASE 2016, Mayo Clinic study, echocardiography, aortic flow rate, patient risk stratification
News | Cardiovascular Ultrasound| June 13, 2016
Researchers from Mayo Clinic believe they have found a better way to risk stratify some of their most fragile patients.
GE Healthcare, Getinge Group, Maquet, Discovery IGS 730 angiography system, Magnus operating table, integrated, hybrid OR

GE Healthcare's Discovery IGS 730 angiography system

Technology | Hybrid OR| June 13, 2016
GE Healthcare and Getinge Group announced the U.S. launch of a new, highly flexible angiography solution for surgery,...
Inventory management, cath lab inventory management, automated inventory management
Sponsored Content | Webinar | Inventory Management| June 10, 2016
Do you find products are stocked based on intuition rather than actual utilization based on clinical demand?
hemmorhagic stroke, blood pressure management, ATACH II trial, NINDS

Brain scan showing damage caused by bleeding during a hemorrhagic stroke. Image courtesy of Adnan I Qureshi, M.D., University of Minnesota.

News | Stroke| June 09, 2016
June 9, 2016 — An international stroke study
Overlay Init