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Innoblative Receives Breakthrough Device Designation for SIRA RFA Electrosurgical Device in Breast Cancer Treatment
Innoblative Designs, Inc. is a private medical device company focused on addressing unmet clinical needs for breast cancer patients. Recently, the company announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its SIRA RFA Electrosurgical Device (SIRA), which is intended to be used in breast cancer patients undergoing breast-conserving surgery (BCS), also known as lumpectomy.
Conventional radiofrequency (RF) ablation has been shown to be effective in reducing the need for reoperations and may also reduce local recurrence in breast cancer treatment. However, traditional RF devices are not optimized for treating lumpectomy cavities, leading to variable treatment depths and incomplete ablations. The SIRA device, on the other hand, has a unique spherical shape that allows it to deliver RF energy circumferentially to the entire cavity, resulting in reproducible ablation depths and providing greater confidence in a consistent thermal effect.
“The SIRA technology is an exciting advancement in the treatment of breast cancer as it is designed to allow surgeons to address potential residual cancer in the lumpectomy cavity at the time of the initial procedure,” commented Dr. Thomas Frazier, Medical Director, Comprehensive Breast Center at Bryn Mawr Hospital in Pennsylvania. “Designed to augment the lumpectomy procedure, the SIRA device aims to reduce the need for reoperations.”
Innoblative’s SIRA device has the potential to be a game changer in breast cancer treatment. By reducing the need for reoperations, it could reduce the physical and emotional burden on patients and improve their overall quality of life. In addition, it has the potential to lower healthcare costs by reducing the number of follow-up procedures needed.
“We believe the SIRA will be a game changer in BCS for breast cancer and we look forward to bringing this important technology to cancer patients,” said Richard Stark, CEO of Innoblative. The company plans to present data supporting the breakthrough device designation at the 24th Annual Meeting for The American Society of Breast Surgeons in Boston, which is scheduled to take place on April 26-30, 2023.
Receiving Breakthrough Device Designation from the FDA is a significant achievement for Innoblative and underscores the potential importance of the SIRA device in breast cancer treatment. The designation is intended to expedite the development and review process of the device and is reserved for medical devices that have the potential to offer significant advantages over existing treatments for life-threatening or irreversibly debilitating diseases.
For more information please contact Matthew Sheridan at Matthew@SpotlightFamilyOffice.com.