CSI presents late-breaking data at ISET 2013

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Cardiovascular Systems announced on 23 January 2013 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.

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, Cardiology and Interventional Associates, Dallas, USA. “Orbital atherectomy led to low bailout-stent usage, low adverse procedural-event rates and improved lesion compliance. Additionally, smaller randomised studies point to improved vessel durability and long-term outcomes—both of which are a first for atherectomy trials in the peripheral vascular space.”

David L Martin, CSI president and chief executive officer said: “CONFIRM reinforces the effectiveness of CSI’s orbital atherectomy in treating ‘real world’ patients. The dataset presented at ISET is the largest ever for peripheral arterial disease, 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 peripheral arterial disease 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 maximise the luminal gain, while the second and third study focused on removing calcium to change vessel compliance. Each study utilised a progressively smaller crown which reduced slow flow, vessel closure and spasms.

Data show that vessel preparation with CSI’s orbital atherectomy system enables low-pressure adjunctive balloon angioplasty across the studies, with low procedural events and bail-out 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 embolisation

 

 

n/a

 

 

2.2%

 

 

2.2%

Vessel Closure

 

 

2.1%

 

 

1.2%

 

 

1.4%

 

 

 

 

 

 

 

 

 

 


 

CALCIUM 360° study 12-month results
Also presented at ISET: “Comparison of Orbital atherectomy plus balloon angioplasty vs. balloon angioplasty alone in patients with critical limb ischemia: Results of the CALCIUM 360 randomised pilot trial,” by Jonathan Ellichman, Southern Cardiovascular, Memphis, USA. Results demonstrate that orbital atherectomy treatment with low-pressure percutaneous transluminal angioplasty safely restores flow in patients with critical limb ischemia and reduces major serious adverse events, compared to angioplasty alone.

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

 

 

 

 

 

 

 

 

 

 

Orbital atherectomy plus

 

 

Angioplasty alone

 

 

 

angioplasty

 

 

 

Mean inflation

 

 

5.9 atms

 

 

9.4 atms

Dissections

 

 

3.4%

 

 

17.1%

Perforation

 

 

0%

 

 

2.8%

Distal embolisation

 

 

0%

 

 

2.8%

Bailout stenting

 

 

6.9%

 

 

14.3%

Freedom from major serious adverse events

 

 

93.3%

 

 

57.9%

           

 

CALCIUM 360° is a prospective, multicentre, randomised study that compared treatment of below-the-knee lesions with orbital atherectomy versus angioplasty alone. All 50 patients had critical limb ischaemia 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, Mid-Florida Cardiology Specialists, Orlando, USA, and Raymond Dattilo (presenter), St Francis Health Center, Topeka, USA, presented “Cost consequences of Orbital atherectomy plus angioplasty vs. angioplasty alone for treatment of calcified femoropopliteal lesions” in a poster session at ISET.

Data show 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.

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