Endomagnetics Achieves CE Approval for Sienna+™ Tracer

Endomagnetics Achieves CE Approval for Sienna+™ Tracer

Endomagnetics has announced achieving CE approval for the sale of its magnetic tracer material, branded Sienna+™.

The injectable tracer is used in combination with the ultra-sensitive SentiMag® instrument in sentinel lymph node biopsy (SLNB), currently the standard of care in tracking the spread of breast cancer.

The SentiMag® instrument itself has also been CE approved, so clinicians across Europe now have available a complete system to be used in place of conventional radioisotopes. The need for special handling of radioactive materials means that many hospitals and clinics are not able to use them. As a result, as many as half of the patients in the West who would benefit from the SLNB technique are not able to access it, and availability is much worse still in other parts of the world.

Endomagnetics’ development of the SentiMag® and Sienna+™ system allows best practice SLNB to be performed anywhere, by any practitioner, without substantially changing their working practice. The combined system offers reduced workflow complexity with a corresponding reduction in procedural cost.

“Achievement of CE approval for Sienna+™ is an important milestone for Endomagnetics and our ability to deliver a complete solution to the market,” says Dr Eric Mayes, CEO of Endomagnetics. “It demonstrates that the system has met rigorous EU safety, health and environmental requirements.”

Endomagnetics recently showed its technology at the San Antonio Breast Cancer Symposium and received an enthusiastic reception from oncologists and surgeons from many countries.

When it comes to sentinel node biopsies, there are numerous problems with Technetium-99m (99mTc) isotope used nowadays to tag the lymph nodes. It is a short-lived, gamma-emitting substance. It has myriads of public safety concerns. It is not available at remote hospitals, either because of logistics of transportation or the need for a radiopharmacy.

36dgwert Medgadget Meets CEO of EndoMagnetics, a Cancer Staging CompanyAt the Future Health Mission 2011 in San Francisco last week, we met with Dr. Eric Mayes, CEO of Endomagnetics, a University College London spinoff that is working on new technology for sentinel node biopsies. The company believes that its product, an instrument dubbed SentiMag, can do as good a job with nano magnetic tracers staging cancer as Technetium-99m and a Geiger counter. And European Commision seems to agree. In December 2010, the company was given CE Mark of approval for the SentiMag, an “ultrasensitive hand-held probe that is capable of detecting magnetic materials in the human body.”

Here’s Dr. Mayes answering our questions about Endomagnetics, its technology, and the company’s future:

More from the product page:

Following safe and proven medical practice, a magnetic tracer is injected near the tumour to provide a trackable signal. The SentiMag™ is then used by surgeons to locate the lymph node closest to the tumour – a vital step to determining whether or how far the cancer has spread.

SentiMag™ uses magnetic tracers that are administered by the surgeon as part of SLNB procedures. It represents an effective and valuable alternative to nuclear medicine for node detection, and so enables the latest medical practice to be offered in a greater variety of hospitals.

Importantly, SentiMag™ requires minimal clinician re-training, and the method puts the surgeon in control, improving workflow and making best practice available to all. The SentiMag™ is based on a patented design that self corrects against electrical, mechanical and thermal noise, offering the world’s best sensitivity.

News

UK Trade & Investment British Business Embassy

Endomagnetics Selected for Britain Showcase

Endomagnetics has been selected as one of the companies to represent the excellence of British business in a Life Sciences Sector Summit on 2nd August.

The SentiMag® and Sienna+® device system greatly improves the availability of sentinel lymph node localisation for surgeons and their patients. When a cancer spreads, it first travels to the lymph nodes. Lymph nodes are small bean-shaped organs, ranging 2-20 millimetres in size that act as

Source : http://medgadget.com/2011/01/medgadget_meets_ceo_of_endomagnetics_a_cancer_staging_company.html

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