Cairn Surgical Launches Innovative Locator for Breast Cancer Surgery
Cairn Surgical Launches Innovative Locator for Breast Cancer Surgery
Cairn Surgical, Inc., a pioneering medical technology firm, recently achieved a significant milestone in breast cancer surgery with the first commercial use of its novel Breast Cancer Locator (BCL™) System. This innovative device aims to transform breast conserving surgery, making procedures more precise and effective for patients dealing with breast cancer.
First Successful Use of the BCL System
In a recent operation, Prof. Dr. med. Hisham Fansa, who leads the Breast Center and the plastic surgery department at a notable Swiss hospital, successfully utilized the BCL System. This technology has been meticulously developed to assist surgeons in identifying tumor characteristics such as shape, size, and specific location, thus facilitating clearer margins during lumpectomy procedures.
Positive Initial Outcomes
Prof. Dr. Fansa expressed his enthusiasm about the launch, emphasizing the importance of this technology in achieving outstanding surgical results. "In our first commercial case, we noted a negative margin, which indicates complete removal of detectable cancer," he remarked. This encourages hope not only for enhanced surgical outcomes but also for reducing the likelihood of patients needing subsequent surgeries.
Significance of the BCL System
The BCL System's design focuses on decreasing positive margin rates while enhancing the efficiency of breast conserving surgery. This involves performing a specialized supine MRI to capture the breast in a surgical position, which is then transformed into a 3D-printed model that precisely matches the patient's breast contours. This model serves as a critical aid during surgery, allowing surgeons to precisely locate and excise tumors.
Advanced Surgical Techniques
During operations, healthcare providers utilize the BCL along with a real-time interactive 3D image called the Visualizer. This combination offers surgeons crucial data throughout the tumor excision process, making the surgical experience more reliable than ever before. By leveraging this advanced technology, surgeons can significantly lower risks and improve patient outcomes.
Clinical Studies and Future Outlook
Cairn Surgical is also committed to presenting clinical data from a multicenter European post-market study involving 33 patients in the near future. Earlier studies have indicated that the BCL System consistently achieves clear tumor margins across various cases. For instance, published results in leading surgical journals validate its effectiveness and the accuracy of resections performed using the BCL System.
The Path to U.S. Approval
Currently, Cairn Surgical is engaged in a pivotal trial involving 448 participants across up to 25 centers in the U.S. This research is crucial for obtaining FDA approval and expanding the accessibility of the BCL System in the United States. The primary focus of this trial is to evaluate the positive margin rate while also assessing various surgical factors, including specimen volumes and operative time.
About Cairn Surgical
Cairn Surgical, Inc. is at the forefront of revolutionizing breast cancer surgery by developing patient-specific surgical guides through the use of advanced imaging and 3D printing technologies. While the Breast Cancer Locator is available in select regions of Europe, it remains an investigational device in the U.S., limited to clinical studies.
Frequently Asked Questions
What is the Breast Cancer Locator System?
The Breast Cancer Locator (BCL™) System is a groundbreaking tool designed to assist surgeons in accurately locating and excising tumors during breast conserving surgery.
Who performed the first commercial operation using the BCL System?
Prof. Dr. med. Hisham Fansa, head of the Breast Center in Switzerland, conducted the inaugural commercial case using the BCL System.
What are the benefits of using the BCL System?
The BCL System enhances surgical precision, improves outcomes by achieving clear margins, and may lower the chances of requiring additional surgeries.
How was the BCL System developed?
The BCL System was developed using advanced imaging techniques combined with 3D printing to create patient-specific surgical guides tailored to individual tumor characteristics.
What is the current status of the U.S. pivotal trial for the BCL System?
The U.S. pivotal trial is ongoing, aiming to enroll 448 women to support FDA clearance and ensure broader access to this innovative technology.
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