Philips releases latest data reinforcing the safety profile of its Stellarex low-dose Drug-Coated Balloon

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Overig advies 23/01/2019 17:14
Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the release of the latest pooled analysis of patient-level data of over 2,300 patients treated with Philips’ Stellarex Drug-Coated Balloon (DCB) in above-the-knee (ATK) studies, which reinforces the strong safety profile of Stellarex. The independent, third party pooled analysis demonstrated low mortality rates through three years after the treatment with no device-related deaths.

Sean Lyden, MD and Chairman of the Department of Vascular Surgery, Cleveland Clinic (US), presented the data at the ‘Long-term safety of drug-eluting technologies in the leg – recent findings, controversies and future outlook’ symposium at the 2019 Leipzig Interventional Course (LINC) in Leipzig, Germany.

“The LINC session provided important new patient-level data regarding mortality in patients with peripheral arterial disease receiving paclitaxel devices – stents or DCBs – to restore and maintain blood flow in the superficial femoral and popliteal arteries in their legs,” said William Gray, MD, FACC, FSCAI, and President of the Lankenau Heart Institute and investigator for the Stellarex clinical trials. “The data from the Stellarex clinical trial programs was strong, and represented over 2,300 patients. When the three-year-outcomes were examined, there were no cardiovascular or non-cardiovascular mortality differences between the groups treated with Stellarex and the control arm. This is very reassuring, and this patient-level data will be amalgamated with other paclitaxel device data in order to complete the analysis. These efforts are already underway, as is a publication specifically regarding these Stellarex results.”

“Based on this latest patient-level analysis, we remain confident in the safety and performance of our unique Stellarex low-dose Drug-Coated Balloon,” said Chris Barys, Business Leader, Image Guided Therapy Devices at Philips. ”We will continue to communicate any relevant findings we obtain, to ensure our physicians have the most current information on our technologies for optimal treatment of their patients.”

Philips’ image-guided therapy solutions include interventional imaging systems, smart devices, software and services that enable clinicians to decide, guide, treat and confirm the appropriate cardiac and peripheral vascular treatment. By designing intelligent technologies and services that help clinicians to deliver a consistent standard of care, optimize care pathways and integrate workflows, Philips is enabling better patient and population outcomes.

The Stellarex DCB is designed to restore and maintain blood flow to arteries in patients with peripheral arterial disease and is FDA approved and CE Marked in the US and Europe.

Philips and the American Heart Association join forces to increase global survival rates of sudden cardiac arrest

The Philips and American Heart Association Connected Pulse Program first-of-a kind initiative, combines education, training and technology for an integrated customized solution in major metropolitan areas around the world

Amsterdam, the Netherlands and Dallas, Texas – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, and the American Heart Association, the world’s leading voluntary health organization devoted to a world of longer, healthier lives, today announced a collaboration to increase sudden cardiac arrest (SCA) survival rates in densely populated cities around the world. The Connected Pulse program leverages a unique end-to-end solution combining education programs to increase awareness of CPR, the use of publicly-available AEDs (Automated External Defibrillator), and new technologies to strengthen the ‘chain of survival’ from the moment an incident occurs to the patient reaching the hospital.

Cardiovascular disease is a leading cause of global mortality, accounting for almost 17 million deaths annually – 31 percent of all deaths [1]. It is estimated that 70 to 80 percent of SCAs happen outside the hospital [2]. For every minute that passes without CPR and defibrillation, a SCA victim’s chance of survival decreases by seven to 10 percent [3]. These cardiac arrests can happen anywhere, at any time. With bystander intervention and treatment with an AED, the survival triples to 31.4 percent [4].

“Philips is dedicated to providing integrated cardiology solutions with a focus on prevention, diagnosis and treatment,” said Frans van Houten, CEO, Royal Philips and member of the American Heart Association CEO Roundtable, a leadership collaborative of 40-plus members who collectively represent more than 10 million employees and their family members to tackle the biggest workforce health challenges. “By joining with the American Heart Association to offer a large-scale, integrated suite of services and expertise, we have the opportunity to make a significant positive impact on the chances of survival from sudden cardiac arrests that occur outside of the hospital, especially in major cities with huge populations.”

“This alliance marks the first time two major global organizations have come together to offer a worldwide, scalable solution to increase out-of-hospital sudden cardiac arrest survival rates,” said Nancy Brown, CEO of the American Heart Association. “When we educate everyone about the life-saving skill of CPR and make AEDs readily available, we increase the chance of survival for all people. Together with Philips, we’ve combined trusted science and innovative health technology to create a positive health impact in all communities around the world.”

Connected Pulse: strengthening the chain of survival for sudden cardiac arrest
By leveraging technology to better connect victims and rescuers – both professional and lay responders – the Connected Pulse program helps optimize improved outcomes within the four critical steps of the chain of survival: 1) alerting emergency medical services; 2) giving CPR to the patient; 3) delivering treatment using an AED; and 4) advanced critical life support, provided by the emergency medical services. Training and awareness programs increase the likelihood of a lay responder being on-hand to provide CPR and treatment using an AED. In addition to the AEDs themselves, technology applications including mapping AEDs and automated alerting of nearby lay responders have the potential to significantly strengthen the chain of survival and increase survival rates.

Components of the customized end-to-end solution from Philips and the American Heart Association will include:•GPS positioning – identifies the nearest available AED and a CPR certified person in close proximity to help assist.
•Command center application – software intelligently guides dispatch operators to coordinate care delivery to the patient during an SCA event.
•Integration and analytics engine – using industries standards, the solution will provide data driven decision making to enable smooth data transfer across systems.
•Telephone CPR training – dispatch operators give hands-only CPR instructions over the phone until the emergency responders arrive. Out-of-hospital cardiac arrest (OHCA) patients who receive Telephone CPR are 64 percent more likely to survive to discharge than OHCA patients who do not receive CPR [5].
•Updated EMS Training – ensures first responders receive competency-based training on CPR and assess gaps to identify where better training is needed.
•Training Kiosks – interactive touch screens offer a 30-second CPR test, currently available in 32 high traffic areas in the U.S. including airports. More than 160,000 people have been trained on the kiosks.
•CPR in Schools Training kit – easy to use kit contains content to train 10 to 20 students at a time.
•AHA Training centers – currently available in 80 countries across the world, including China, Brazil, Japan, Mexico, United Arab Emirates, Italy and India.
•Public Education Training Campaign – drives awareness of symptoms of cardiac arrest and helps promote bystander education.
•In hospital CPR quality improvement through RQI (Resuscitation Quality Improvement) program – low-dose, high-frequency quarterly skills sessions improve CPR competency and are setting a new standard of resuscitation and patient care currently at more than 400 hospitals and for over 300,000 healthcare professionals in the U.S.
•Heartsaver Hero Award program – recognizing anyone who has been part of the chain of survival in any way with a Heartsaver Hero Award within the community.
•Consultancy, design and delivery – With its vast experience in health care transformation programs, the American Heart Association and Philips will consult, co-create, design and manage the implementation of the program as a turnkey solution to meet the needs of specific communities.

Philips and the AHA expect to announce the first pilot cities participating in the program in 2019. To learn more about the Connected Pulse program, visit

[1] World Health Organization -
[2] Cardiac Arrest vs Heart Attack, American Heart Association, September 16, 2016
[3] AHA Releases 2015 Heart and Stroke Statistics, Sudden Cardiac Arrest Foundation, September 16, 2016
[4] Response to Cardiac Arrest and Selected Life-Threatening Medical Emergencies, Mary Fran Hazinski; et al, American Heart Association, September 16, 2016

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