AVM treatment

Disclaimer

Product availability is subject to country regulatory clearance. Please contact your local sales representative to check the availability in your country.

References

1.  In routine neuro endovascular procedures*, the AlluraClarity system with ClarityIQ technology may reduce patient dose (as dose-area product) by as much as 62% (in routine diagnostic neuro endovascular procedures) and as much as 65% (in routine interventional neuro endovascular procedures)** for the total procedure without affecting the procedural performance (fluoroscopy time and number of DSA images) as compared to equivalent procedures on an Allura Xper system, as demonstrated in one single-center study.*** 
   
   *Routine neuro interventions comprise of DSA and fluoroscopy usage. ** (95% CI 56%, 68% for routine diagnostic neuro endovascular procedures, 95% CI 58%, 71% for routine interventional neuro endovascular procedures). The results of the application of dose reduction techniques will vary depending on the clinical task, patient size, anatomical location and clinical practice. The interventional radiologist assisted by a physicist as necessary has to determine the appropriate settings for each specific clinical task. *** Results based on total dose area product from a single center retrospective historically controlled cohort study (Karolinska Hospital - Solna, Sweden) on 614 patients (302 for Allura Xper and 312 for AlluraClarity) undergoing neuro endovascular procedures. [Söderman M, Mauti M, Boon S, Omar A, Marteinsdóttir M, Andersson T, Holmin S, Hoornaert B. Radiation dose in neuroangiography using image noise reduction technology: a population study based on 614 patients. Neuroradiology. 2013; 55:1365-1372]
2. 3D reconstructions at higher resolution settings may take longer times
3. Söderman M, Holmin S, Andersson T, Palmgren C, Babic D, Hoornaert B. Image noise reduction algorithm for digital subtraction angiography: clinical results. Radiology. 2013 Nov;269(2):553-60.The results of the application of dose reduction techniques will vary depending on the clinical task, patient size, anatomical location and clinical practice. The interventional radiologist assisted by a physicist as necessary has to determine the appropriate settings for each specific clinical task. Results based on DSA dose area product per frame from a single center prospective randomized study on 20 patients. DSA runs for Allura Xper with ClarityIQ and Allura Xper without ClarityIQ were acquired on the frontal and lateral channel on the same patient under same condition of geometry, field of view, and injection protocol. Image quality was based on subjective assessment (score 1-5, 1=very poor, 5=excellent, blinded review by 3 radiologists involved in the study).
4. In a simulation study with over 60 users globally, results obtained during user tests performed in the period of November 2015-February 2016. The tests were designed and supervised by Use-Lab GmbH, an independent and objective usability testing engineering consultancy and user interface design company. The tests involved 31 US-based clinicians (16 physicians and 15 technicians) and 30 European-based clinicians (15 physicians and 15 technologists), who performed procedures using Azurion in a simulated interventional lab environment.
5. Evaluated with clinical users in a simulated lab environment with a total of 17 teams consisting of a physician and a radio-tech with different levels of experience.
   *The user level of expertise required is described in the Instructions for Use as the Intended Operator Profile.
   **3D reconstructions at higher resolution settings may take longer times.