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    NFP, an Aon company, Expands Private Wealth Offering with Acquisition of Metis Ireland

    Roche receives CE mark for new blood test to detect Alzheimer’s pathology: Elecsys® plasma phosphorylated-tau 217 (pTau217).

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    Air India rationalises international route network through August 2026, to continue operating 1,200+ international flights every month .

    Roche receives CE mark for new blood test to detect Alzheimer’s pathology: Elecsys® plasma phosphorylated-tau 217 (pTau217).

    L&T Technology Services and Emerson Announce a Global Cooperation and Strategic Engagement to Drive Innovation in Engineering Excellence

    Fertiliser stocks for Kharif 2026 reach over 51% of assessed requirement significantly higher than the usual level of about 33%

    Viksit Bharat – Guarantee for Rozgar and Ajeevika Mission (Gramin), 2025:

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    Adani Airport Holdings, IHG Hotels & Resorts Sign Five -Hotel Deal; Kimpton Enters India .

    AI-Powered Financial Inclusion in India

    Tata Motors Limited (formerly TML Commercial Vehicles Ltd.) Q4 & full year FY26 Results.

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    Global health gains face threat of reversal .

    Roche receives CE mark for new blood test to detect Alzheimer’s pathology: Elecsys® plasma phosphorylated-tau 217 (pTau217).

    DKMS Foundation Hosts ‘Lifesaver Honours Night’ to Celebrate Changemakers in the Fight Against Blood Cancer.

    DKMS Foundation India Launches Free HLA Typing for Children with Thalassaemia.

    Dr. Mansukh Mandaviya to inaugurate 100-bedded ESIC Hospital at Doddaballapur, Karnataka on 3rd May

    Strengthening healthcare infrastructure is essential -Dinesh Gundu Rao,Minister for Health & Family Welfare.

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    AI-Powered Financial Inclusion in India

    The AI Reckoning: 73% of Executives Report Underwhelming ROI from AI Efforts as Focus Shifts from Hype to High-Stakes Pressure Testing

    Roche receives CE mark for new blood test to detect Alzheimer’s pathology: Elecsys® plasma phosphorylated-tau 217 (pTau217).

    India’s AI Boom Faces Reality Check as ROI and Governance Lag: ISACA Report.

    CAQM conducts inspection drive in Noida, directs Intensified Mitigation and Strict Enforcement

    National Health Authority concludes AB PM-JAY Auto-Adjudication Hackathon Showcase 2026 at IISc Bengaluru; winning teams awarded

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    Tata Motors Limited (formerly TML Commercial Vehicles Ltd.) Q4 & full year FY26 Results.

    ROLLS-ROYCE INTRODUCES NEW BESPOKE CRAFTS INSPIRED BY FIVE CENTURIES OF DECORATIVE ARTS.

    Porsche streamlines the Executive Board: Car-IT to be part of R&D in the future.

    Renault 4 E-Tech electric Plein Sud: open-top adventure from €37,290

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    Macneil Noronha named replacement for injured Ramakrishna Ghosh.

    9th Edition of Save Water Cup 2026 Inaugurated at Gopalan Cricket Ground.

    IBM Launches Sports Tech Startup Challenge at Web Summit Vancouver .

    Kriish Tyagi, Manish, Mukund enter pre-quarters at Karnataka Open.

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    Actor Dr. Rajkumar’s 97th birthday celebration on April 24th, at 10.30 am in Dr. Rajkumar Punyabhoomi premises of the Sri Kanteerava Studio .

    Doordarshan Chandana has launched an innovative farmers’ reality show named “Raitaratna” (ರೈತರತ್ನ).

    Phoenix Marketcity brings you a legendary live concert by PADMA BHUSHAN KS CHITRA.

    UNDP Goodwill Ambassador and ‘Game of Thrones’ star Nikolaj Coster-Waldau highlights Odisha’s mangrove restoration story in global documentary series

    House of McDowell’s Soda Yaari Jam, India’s Biggest Branded Live IP, Touches down in Kolkata

    “Virgin Boys” – A Bold Telugu Youth Drama Captures Hearts Across Theatres

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    Air India rationalises international route network through August 2026, to continue operating 1,200+ international flights every month .

    Roche receives CE mark for new blood test to detect Alzheimer’s pathology: Elecsys® plasma phosphorylated-tau 217 (pTau217).

    DKMS Foundation Hosts ‘Lifesaver Honours Night’ to Celebrate Changemakers in the Fight Against Blood Cancer.

    Jammu Directly Linked with Kashmir via Passenger Train for the First Time .

    D2C Nutrition Brand Beast Life Launches World’s First Clinically Studied Nano Creatine ‘Creatine Nano 400’; Targets ₹500 Crore ARR in Next 3 Years

    Athulya Senior Care Inks Landmark MoU with SingHealth to Advance Senior Care, Training, and Research Collaboration.

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    Air India rationalises international route network through August 2026, to continue operating 1,200+ international flights every month .

    Global health gains face threat of reversal .

    IBM Launches Sports Tech Startup Challenge at Web Summit Vancouver .

    The AI Reckoning: 73% of Executives Report Underwhelming ROI from AI Efforts as Focus Shifts from Hype to High-Stakes Pressure Testing

    NFP, an Aon company, Expands Private Wealth Offering with Acquisition of Metis Ireland

    Roche receives CE mark for new blood test to detect Alzheimer’s pathology: Elecsys® plasma phosphorylated-tau 217 (pTau217).

  • National
    • All
    • Economy & Politics
    • Election

    AI-Powered Financial Inclusion in India

    Air India rationalises international route network through August 2026, to continue operating 1,200+ international flights every month .

    Roche receives CE mark for new blood test to detect Alzheimer’s pathology: Elecsys® plasma phosphorylated-tau 217 (pTau217).

    L&T Technology Services and Emerson Announce a Global Cooperation and Strategic Engagement to Drive Innovation in Engineering Excellence

    Fertiliser stocks for Kharif 2026 reach over 51% of assessed requirement significantly higher than the usual level of about 33%

    Viksit Bharat – Guarantee for Rozgar and Ajeevika Mission (Gramin), 2025:

  • Business

    Adani Airport Holdings, IHG Hotels & Resorts Sign Five -Hotel Deal; Kimpton Enters India .

    AI-Powered Financial Inclusion in India

    Tata Motors Limited (formerly TML Commercial Vehicles Ltd.) Q4 & full year FY26 Results.

  • Health

    Global health gains face threat of reversal .

    Roche receives CE mark for new blood test to detect Alzheimer’s pathology: Elecsys® plasma phosphorylated-tau 217 (pTau217).

    DKMS Foundation Hosts ‘Lifesaver Honours Night’ to Celebrate Changemakers in the Fight Against Blood Cancer.

    DKMS Foundation India Launches Free HLA Typing for Children with Thalassaemia.

    Dr. Mansukh Mandaviya to inaugurate 100-bedded ESIC Hospital at Doddaballapur, Karnataka on 3rd May

    Strengthening healthcare infrastructure is essential -Dinesh Gundu Rao,Minister for Health & Family Welfare.

  • Technology
    • All
    • Environment
    • Science

    AI-Powered Financial Inclusion in India

    The AI Reckoning: 73% of Executives Report Underwhelming ROI from AI Efforts as Focus Shifts from Hype to High-Stakes Pressure Testing

    Roche receives CE mark for new blood test to detect Alzheimer’s pathology: Elecsys® plasma phosphorylated-tau 217 (pTau217).

    India’s AI Boom Faces Reality Check as ROI and Governance Lag: ISACA Report.

    CAQM conducts inspection drive in Noida, directs Intensified Mitigation and Strict Enforcement

    National Health Authority concludes AB PM-JAY Auto-Adjudication Hackathon Showcase 2026 at IISc Bengaluru; winning teams awarded

  • Auto

    Tata Motors Limited (formerly TML Commercial Vehicles Ltd.) Q4 & full year FY26 Results.

    ROLLS-ROYCE INTRODUCES NEW BESPOKE CRAFTS INSPIRED BY FIVE CENTURIES OF DECORATIVE ARTS.

    Porsche streamlines the Executive Board: Car-IT to be part of R&D in the future.

    Renault 4 E-Tech electric Plein Sud: open-top adventure from €37,290

  • Sports

    Macneil Noronha named replacement for injured Ramakrishna Ghosh.

    9th Edition of Save Water Cup 2026 Inaugurated at Gopalan Cricket Ground.

    IBM Launches Sports Tech Startup Challenge at Web Summit Vancouver .

    Kriish Tyagi, Manish, Mukund enter pre-quarters at Karnataka Open.

  • Entertainment

    Actor Dr. Rajkumar’s 97th birthday celebration on April 24th, at 10.30 am in Dr. Rajkumar Punyabhoomi premises of the Sri Kanteerava Studio .

    Doordarshan Chandana has launched an innovative farmers’ reality show named “Raitaratna” (ರೈತರತ್ನ).

    Phoenix Marketcity brings you a legendary live concert by PADMA BHUSHAN KS CHITRA.

    UNDP Goodwill Ambassador and ‘Game of Thrones’ star Nikolaj Coster-Waldau highlights Odisha’s mangrove restoration story in global documentary series

    House of McDowell’s Soda Yaari Jam, India’s Biggest Branded Live IP, Touches down in Kolkata

    “Virgin Boys” – A Bold Telugu Youth Drama Captures Hearts Across Theatres

  • Lifestyle
    • All
    • Food
    • Travel

    Air India rationalises international route network through August 2026, to continue operating 1,200+ international flights every month .

    Roche receives CE mark for new blood test to detect Alzheimer’s pathology: Elecsys® plasma phosphorylated-tau 217 (pTau217).

    DKMS Foundation Hosts ‘Lifesaver Honours Night’ to Celebrate Changemakers in the Fight Against Blood Cancer.

    Jammu Directly Linked with Kashmir via Passenger Train for the First Time .

    D2C Nutrition Brand Beast Life Launches World’s First Clinically Studied Nano Creatine ‘Creatine Nano 400’; Targets ₹500 Crore ARR in Next 3 Years

    Athulya Senior Care Inks Landmark MoU with SingHealth to Advance Senior Care, Training, and Research Collaboration.

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Philips announces first U.S. patient enrolled in ILLUMENATE study of Stellarex 0.014 Drug-Coated Balloon for below-the-knee peripheral artery disease

Study will assess safety and effectiveness of treatment that restores adequate blood flow in legs of patients to reduce repeat revascularizations and amputations of major lower limbs To find out more about Philips’ image-guided therapy solutions visit us at VEITHsymposium in the Philips pavilion (Nassau Suites), taking place in New York, November 13-16.

by FWM
November 12, 2018
in Health
0

The Stellarex 0.014” OTW Drug-Coated Balloon is designed to restore and maintain blood flow to arteries in patients with PAD.

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Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced enrollment of the first U.S. patient in the Stellarex ILLUMENATE Below-the-Knee (BTK) Investigational Device Exemption (IDE) study, led by principal investigators Dr. Bill Gray and Dr. Mahmood K. Razavi. This unique global, prospective, randomized, multi-center trial is designed to assess safety and effectiveness of the Stellarex 0.014 drug-coated balloon versus percutaneous transluminal angioplasty (PTA) in patients with critical limb ischemia (CLI). The trial will enroll 354 patients at 45 sites in U.S., Europe and Australia in the next 12-18 months. The first patient in the U.S. was enrolled by Dr. Craig Walker at the Cardiovascular Institute of the South in Houma, Louisiana.

This study will look at findings that continue to demonstrate the benefits of the Stellarex 0.014 Drug-Coated Balloon for BTK peripheral artery disease (PAD) and its safety and durability for patients.

Mahmood K. Razavi

MD, FSIR, FSVM, St. Joseph’s Hospital in Orange, CA and principal investigator of the ILLUMENATE BTK study

“Several studies have shown the safety and durability benefits of the Stellarex balloon,” said Mahmood K. Razavi, MD, FSIR, FSVM, St. Joseph’s Hospital in Orange, CA and principal investigator of the ILLUMENATE BTK study. “This study will look at findings that continue to demonstrate the benefits of the Stellarex 0.014 Drug-Coated Balloon for BTK peripheral artery disease (PAD) and its safety and durability for patients. Given the challenging chronic nature of BTK PAD, we are hoping to find that through sustained patency using Stellarex, we can improve healing, and reduce target lesion revascularization and major amputation.”

“Peripheral artery disease below the knee is challenging and Philips is committed to providing proven clinical solutions that positively impact patient outcomes,” said Christopher Barys, Image Guided Therapy Devices Business Leader for Philips. “With Stellarex BTK, we have the potential to improve patient outcomes and decrease re-admission costs for those suffering from this complex disease state, while providing clinicians with the necessary tools to confirm the right therapies for their patients.”   PAD is prevalent in the U.S. and affects around 250 million people worldwide [1]. If left untreated, the condition can lead to chronic limb ischemia (CLI). CLI associated with infrapopliteal arteries behind the knee often involves long calcified segments [2]. The prognosis is worse in elderly patients with severe comorbidities and limited life expectancy [3]. Therefore, the endovascular treatment of CLI remains a challenge for physicians. In the U.S., 160,000 – 180,000 amputations are performed annually, with more than 50 percent of cases having no diagnostic or therapeutic endovascular intervention performed in the year before an amputation [4].     Philips’ image-guided therapy solutions comprise 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 0.014” OTW Drug-Coated Balloon is designed to restore and maintain blood flow to arteries in patients with peripheral arterial disease. The Stellarex 0.014 Drug-Coated Balloon is CE Marked and available in Europe.

Tags: Stellarex ILLUMENATE Below-the-Knee (BTK) Investigational Device Exemption (IDE) study

FWM

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