Indicated for the use in peripheral arteries for:
- Native Bypass
- Artifical Bypass
- Stent Grafts
- In-Stent Restenosis
Refined Atherectomy. Built to Remove.
The Rotarex™ Atherectomy System is designed to efficiently remove both plaque and thrombus by utilizing three distinct mechanisms of action to treat PAD lesions including in-stent restenosis. The device modifies, excises, and aspirates complex lesions with mixed plaque morphology with two different size options—6F & 8F.
We understand that anything that can help to save time and space, and reduce complexity in the lab is essential. The Rotarex™ Atherectomy System is simple to set up and easy to use, with a small plug-and-play capital component and reusable handle that is easily draped. Additionally, the Rotarex™ Atherectomy System does not require any warm up, infusion or catheter clean out.
A meta-analysis of 8 clinical studies comprising data obtained from 2,107 patients studied from 2002 to 2015 was performed to:
|Measure/Outcomes||Mean (95% CI)|
|Age||68.1 (66.4, 69.7)|
|Gender (% Male)||65.3% (60.6%, 70.0%)|
|Rotarex™ Device Treatment Time (minutes)||3.0 (1.3, 4.7)|
|Lesion Length (mm)||153.96 (115.24, 192.69)|
|Technical Success||95.8% (94.3%, 97.3%)|
|Clinical Success||79.9% (75.2%, 84.5%)|
|TLR at 6 Months||7.8% (1.0%, 14.5%)|
|TLR at 12 Months||11.3% (7.4%, 15.3%)|
|Restenosis at 6 Months||16.9% (0.0%, 35.3%)|
|Restenosis at 12 Months||35.5% (19.6%, 51.4%)|
|Measure/Outcomes||Mean (95% CI)|
|ABI at 6 Baseline||0.33 (0.18, 0.47)|
|ABI at 6 Months||0.83 (0.78, 0.88)|
|ABI at 12 Months||0.77 (0.71, 0.82)|
|Rutherford Score at Baseline||3.54 (3.42. 3.67)|
|Rutherford Score at 6 Months||1.51 (1.03, 2.00)|
|Rutherford Score at 12 Months||2.13 (1.83, 2.42)|
|Procedure-Related Dissection||5.9% (3.3%, 8.6%)|
|Procedure-Related Embolization||7.5% (4.7%, 10.4%)|
|Procedure-Related Perforation||2.2% (0.9%, 3.4%)|
|Procedure-Related Pseudo-Aneurysm||1.5% (0.6%, 2.4%)|
|Procedure-Related Abrupt Reocclusion||2.4% (1.0%, 3.7%)|
64-year-old male patient presented with left-sided CLI. Over the preceding four months the patient experienced left-sided rest pain and despite receiving best medical treatment, developed a dry, non-healing ulcer of the toe. Puncture of the right groin and cross-over approach, demonstrated a very long, 31 cm, TASC D, femoropopliteal CTO on angiogram. The SFA occlusion was recanalized with a wire intraluminally, followed by 3 passes of a 6F Rotarex S™ Atherectomy Catheter, after which 3 PTAs resulted in a completely restored flow. The patient remained asymptomatic after 18 months.
February 2022, Cath Lab Digest
Leipzig’s Experience Using Rotarex™ Rotational Excisional Atherectomy for In-Stent Reocclusion in Peripheral Arterial Occlusive Disease
Oct 17, 2021, PR News Wire
BD Announces 510(k) Clearance of Expanded Indications for the Rotarex™ Atherectomy System
September 2020, Cath Lab Digest
Rotational Excisional Atherectomy With the Rotarex™ Atherectomy Device – Miguel Montero-Baker, MD
Webinar with Ian Cawich, MD & Raymond Dattilo, MD, FACC
Refining Atherectomy in Challenging Lesions with Mixed Plaque Morphology
Webinar with George Adams, MD
Atherectomy with Thrombectomy: The Rotarex Rotational Excisional Atherectomy System
Jun 1, 2020
BD Completes Acquisition of Straub Medical
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Please consult product labels and inserts for indications, contraindications, hazards, warnings, precautions and directions for use.