New clinical study shows important step in improving safety for patients and staff during cardiac interventions - 50% less X-ray dose

For the first time in cardiac interventional imaging, Philips’ new live image guidance technology AlluraClarity enables interventions to be performed with 50% less X-ray dose while maintaining equal image quality.

Paris, France – Royal Philips (NYSE: PHG, AEX: PHIA), together with DutchSt. Radboud University Medical Center and German Main-Taunus Cardiac Center, today announced the results of a new clinical study that demonstrate safety for both cardiac patients and clinicians can be significantly further improved. With Philips’ recently introduced interventional X-ray technology AlluraClarity*, the doctors of the medical center were, for the first time, able to achieve a 50% reduction in X-ray dose while maintaining the excellent image quality needed during cardiac live image-guided interventions. The results will be presented during the annual congress of the European Association for Percutaneous Cardiovascular Interventions (EuroPCR), 21 – 24 May in Paris.

The study, designed by Main-Taunus Cardiac Center in Bad Soden, Germany and conducted at the St. Radboud University Medical Center in Nijmegen, the Netherlands, between September and November 2012, compared two coronary angiography runs of the same patient (across 39 patients in total, with a BMI range of 20 – 37). The first run used conventional Allura Xper technology, while the second run used the new ClarityIQ technology on the Philips AlluraClarity system. Six independent interventional cardiologists from all over Europe (Italy, France, Germany, the Netherlands and Sweden) then evaluated the image quality of these runs, side by side, concluding that compared to conventional X-ray technology, AlluraClarity provided equal quality images for more than 85% of the cases.

“We have extensively explored and tested this new technology at our cardiac center”, said Prof. Dr. med. N. Reifart, co-author of the study and Director of the Main-Taunus Cardiac Center, Private Clinic Bad Soden. “It now enables us to perform most diagnostic angiographies with at least 50% lower radiation levels, with similar image quality as in the past”.

“Such a significant reduction in X-ray dose benefits both patients and the staff managing their care”, said Dr. T.J.F ten Cate, the cardiologist at St. Radboud University Medical Center responsible for conducting the study. “Now that we are using AlluraClarity, we have become more conscious about radiation”.

The study results represent an important milestone for Philips, showcasing how complex interventional procedures can be performed with a significant reduction in X-ray dose. At the end of 2012, Philips announced that it had made a breakthrough in conjunction with the Dutch St. Antonius Hospital, a renowned center of expertise in the field of heart and vascular interventions, with the same X-ray technology, but in a different type of procedure: vascular interventions. Studies in the field of neuroradiology and electrophysiology are ongoing, with results expected soon. To date, since its commercial introduction mid-2012, there have been more than 200 AlluraClarity system installations in regions such as Asia, Europe, the Middle East and Latin America.

“In the medical world, there is a clear shift taking place from open surgery to minimally invasive interventions, procedures that are performed with catheters using live image guidance to diagnose and treat diseases”, commented Ronald Tabaksblat, General Manager, Philips Interventional X-Ray. “The Philips AlluraClarity system proves our commitment to reducing the need to make compromises in patient care. With further studies currently being conducted at a number of different hospitals across Europe that look into reducing radiation for procedures, Philips is truly leading the way in live image-guided interventions.”

Also showcasing at EuroPCR is Philips’ new EchoNavigator live image guidance tool. Visit Philips at EuroPCR 2013 at booth #M41 to learn more or to speak with a Philips representative.

In addition, Dr. T.J.F ten Cate will be giving a presentation at EuroPCR titled: ‘Automated image enhancement significantly reduces radiation dosage in coronary angiography with preserved image quality’ on Thursday, May 23, 10:57 – 11:05 a.m., in room 241.

For more information, please go to www.philips.com/AlluraClarity.

*Philips AlluraClarity with ClarityIQ technology is currently not available for sale in USA, 510(k) pending

For further information, please contact:

Käthryn Cars
Corporate Communications Nordic
Tel +46 (0) 708 32 20 22
E-post: Kathryn.cars@philips.com

Joost Maltha
Philips Healthcare Benelux
Tel: +31 (0)6 10 55 8116
E-mail: joost.maltha@philips.com

Notes for editor

The clinical study demonstrated that the images acquired with the ClarityIQ have similar clinical image quality compared to those acquired using Philips Allura Xper FD10 interventional x-ray system. Cardio angiography films of 39 patients that were acquired at the UMC St. Radboud in Nijmegen, the Netherlands, under normal as well as 50% lower dose acquisition settings in the same patient, using the Allura Xper FD10 system first using the conventional Allura Xper technology and secondly the new Philips AlluraClarity with ClarityIQ technology, for assessing image quality and X-ray dose reduction. The image sets were randomized and masked for acquisition type and date in order to be rated for clinical image quality based on relevant clinical information in an off-line side by side reading study by six experienced interventional cardiologists. The images obtained with ClarityIQ were rated equal or superior to the images obtained with the conventional Allura Xper technology in 85% of the cases.