PR Newswire
Securing this CE mark expands access to the HydroMARK™ Plus markers across Europe, combining proprietary hydrogel technology with features designed to support marker stability and visibility in breast care.
Mammotome, a Danaher company and global leader in breast care innovation, has obtained a CE mark for the HydroMARK™ Plus Breast Biopsy Site Marker, scaling access to the innovative marker technology across Europe for patients undergoing breast cancer diagnosis and treatment.
Designed to enhance tissue adherence and help mitigate marker displacement during surgical excision, the HydroMARK™ Plus markers combine proprietary hydrogel technology with Wings that Cling™, which are exposed wing structures featured on the Dragonfly™ and Hummingbird™ marker shapes.1,2,3 The hydrogel carrier hydrates within 24 hours and is designed to provide ultrasound visibility for up to 12 months, including in patients undergoing neoadjuvant chemotherapy.⁴ Together, these features are intended to support accurate lesion localization.
The HydroMARK™ Plus markers are visible under ultrasound, mammography, and MRI, and are indicated for placement in breast tissue and lymph nodes.⁵
"Mitigating the risk of surgical displacement is a priority for breast care teams as they guide patients through treatment," said Olaf Andrich, General Manager of EMEA at Mammotome. "The HydroMARK™ Plus markers were designed with a focus on marker stability and visibility, giving clinicians greater confidence that the marker will remain with the target tissue during surgery. Obtaining CE mark is an important step in expanding access to this technology across Europe."
The HydroMARK™ Plus markers are part of the comprehensive breast biopsy site marker portfolio offered by Mammotome, providing physicians choice across a range of clinical needs. The HydroMARK™ Plus markers are FDA and Health Canada cleared and CE mark secured, reinforcing an ongoing commitment from Mammotome to expand access to advanced breast care technologies worldwide.
European availability of the HydroMARK™ Plus markers is expected to begin soon, with a phased rollout across select markets. To learn more about the HydroMARK™ Plus markers, please click here.
About Mammotome
At Mammotome, our expertise and compassion for breast care makes us the indispensable partner to physicians, clinicians and patients. Our drive for innovation is rivaled only by our compassion for the people we serve, from the clinicians and surgeons who demand consistently precise solutions, to the patients and families seeking peace of mind. We boast a comprehensive range of products that create better outcomes in breast care and provide physicians and patients with educational resources that guide their journey. Headquartered in Cincinnati, OH, Mammotome has been part of the Danaher Corporation since 2014. The Mammotome brand of products is sold in over 65 different countries throughout the world.
About Danaher
Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health. Through our connected ecosystem of industry-leading businesses, we work side by side with customers to solve their most complex scientific and clinical challenges—helping move innovations from discovery to delivery faster for patients who depend on them. Powered by the Danaher Business System, our advanced science and technology and proven ability to innovate help enable faster, more accurate diagnoses and reduce the time, cost, and risk required to discover, develop, and deliver life-changing therapies. Through continuous improvement and operational excellence, our approximately 60,000 associates worldwide are focused on delivering lasting impact and improving quality of life around the world, while building a healthier, more sustainable tomorrow. Explore more at www.danaher.com.
1. HydroMARK™ Plus Device Test - PCR-000299, SDR0098 Vacuum Suction Testing
2. HydroMARK™ Design Plan - ADD-00013 Rev G, Page 19
3. HydroMARK™ Device Test - PCR-000414, Summative Usability
4. Sakamoto N, Fukuma E, Tsunoda Y, Teraoka K, Koshida Y. Evaluation of the dislocation and long-term sonographic detectability of a hydrogel-based breast biopsy site marker. Breast Cancer. 2018 Sep;25(5):575-582. doi:10.1007/s12282-018-0854-8. Epub 2018 Mar 23. PMID: 29572658 https://doi.org/10.1007/s12282-018-0854-8
5. Indication may not be approved in your region. Please check with your local Mammotome representative.
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