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pinnacle3 smartarc
Philips Medical Systems
Summary: Pinnacle3 SmartArc is a radiotherapy planning system by Philips Medical Systems, primarily used for volumetric-modulated arc therapy (VMAT). Key evidence highlights its effectiveness in optimizing treatment plans for various cancers.
FDA Clearance Information
Pathway
510K
Number
K090808 ↗
Decision Date
April 3, 2009
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Pinnacle3 SmartArc was cleared by the FDA via the 510k pathway on April 3, 2009. It is manufactured by Philips Medical Systems and is classified as a Class 2 device.
What It Is
The Pinnacle3 SmartArc is a radiotherapy treatment planning system designed to optimize volumetric-modulated arc therapy (VMAT) delivery. It is intended for use in planning radiation treatments for cancer patients, enhancing precision and efficiency.
Clinical Applications
Commonly used in the treatment of various cancers, including head and neck, prostate, and Hodgkin lymphoma. It provides clinicians with advanced tools for creating highly conformal radiation treatment plans.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective, and retrospective studies, published between 2016 and 2021. These studies investigate the efficacy and optimization of VMAT using the Pinnacle3 SmartArc system.
Reported Outcomes
Published studies report that the Pinnacle3 SmartArc system enhances treatment plan quality and efficiency in VMAT. It has been shown to improve dose distribution and control over organs-at-risk in cancer treatments, particularly for head and neck and prostate cancers.
Safety Profile
Reported complications include potential variability in treatment plan optimization due to operator dependency. However, no significant adverse events directly related to the Pinnacle3 SmartArc system have been documented in the studies reviewed.
Evidence Limitations
The evidence is limited by the variability in study design and the operator-dependent nature of treatment planning. Further research is needed to standardize optimization processes and evaluate long-term outcomes across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Pinnacle3 SmartArc?
The Pinnacle3 SmartArc is indicated for use in planning VMAT for various cancers, including head and neck, prostate, and Hodgkin lymphoma.
What outcomes have been reported in clinical studies?
Studies report improved treatment plan quality and dose distribution, particularly in head and neck and prostate cancer treatments.
What complications have been reported?
Reported complications include variability in plan optimization due to operator dependency, with no significant adverse events directly linked to the system.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.