The BD EleVation™ Breast Biopsy System from Tempe’s Becton, Dickinson and Company (BD) is designed to provide physicians with a versatile and efficient breast biopsy tool.
Patient Journey
You sit in the radiologist’s waiting room, quietly contemplating how your day would go. Perhaps you’re stopping in for your annual mammogram, which physicians advise for women age 40 and beyond, and you anticipate an uneventful exam. Perhaps something feels wrong – a lump you or your partner spotted, a new and persistent pain, a pang of intuition that something isn’t right – and you’re eager for a physician’s input.
“You might come in 10 times, and 9 times out of 10 it’s nothing,” says Dr. Brian Keehn, a radiologist. “But the one time it is something, you’ll be glad you came in. Better safe than sorry.” You can’t be too safe when it comes to breast cancer screening.
Disease
In the United States, 1 in every 8 women will be diagnosed with breast cancer in their lifetime. This pernicious, but often quite treatable, disease is the second leading cause of cancer death among American women. As of January 2020, there are more than 3.5 million women with a history of breast cancer in the U.S., including those currently in treatment. “Early detection is key, because it allows you more options in treatment,” Keehn says. If you have any concerns or are at a higher risk of breast cancer, stay in close communication with your doctor during COVID-19. “When it comes to women’s health and breast imaging, to the extent possible, I wouldn’t put anything off,” Keehn says. With increased safety and sanitization protocols, “we absolutely are limiting any potential risk.”
Mammograms are usually swift and painless, and results come back within a few days. If everything is great, you go on about your life. If the initial exam or mammogram indicates a suspicious mass, your physician may order additional imaging, such as an ultrasound to determine whether it’s just a benign lump or cyst that doesn’t need any action. If it still looks suspicious, your doctor may recommend a biopsy.
Historically, biopsies have been invasive and unnerving affairs – for patients and physicians. “Our strategy is the passion that we have to make sure that we help to minimize the fear and the impact that diagnostic interventions may have on patients at risk of cancer,” says Rima Alameddine, Vice President and General Manager of the oncology platform at BD.
The oncology team at Becton, Dickinson and Company (BD; bd.com), a global health care technology company with offices in Tempe, saw a need. BD’s oncology engineers and representatives met with doctors and learned about the challenges of existing biopsy tools in order to “understand exactly what it is the customer needs and what need will be able to be addressed with this solution,” Alameddine says. “And then we design it. We test it and have all their inputs to make sure that we’re able to fulfill this need in a way that we can also maximize access. It’s not only about innovative technology; it’s about making sure that our physicians can use it – and not just in the U.S. We are a global company, so we get physicians’ inputs from around the world. This is part of our development process.”
Technology
The result: BD EleVation™ Breast Biopsy System, a sleek, lightweight, ergonomically sophisticated device that can extract a sample in an average of nine seconds. “Certain patients hold their breath the whole time you’re taking your sample,” Keehn says. “If I could do that in 10-15 seconds versus a couple minutes, that really does make a difference.”
BD EleVation™ Breast Biopsy System is a SIMS technology, which means single insertion, multiple samples. Speaking from her own experience, Alameddine says this is a game-changer. “I have gone through several biopsies in my life.When they needed to get a sample – or several samples – every time, they would have to insert the needle, get the sample, extract the needle, remove the sample from the sample notch and then insert the needle again,” she says. “With BD EleVation™ Breast Biopsy, it’s the opposite. With one insertion, it collects multiple samples.”
Keehn has been working with BD products for some time and considers BD EleVation™ Breast Biopsy System “a big jump in BD’s technology.” The fact that it is smaller, battery-operated and cordless is “much preferred, because you can reposition the patient and not be limited on mobility.” Varying needle gauges allow for further customization and fine-tuning. With SIMS capability and an ergonomic handle, the BD EleVation™ Breast Biopsy System was designed with patient and physician comfort in mind.
In early clinical cases with the BD team, Keehn had the opportunity to use the BD EleVation™ Breast Biopsy System in some challenging cases. “When we were going to sample it, we specifically chose some cases that I knew, unfortunately, were going to be positive cancer cases – really bad cancers. I wanted to test the device, and to push it,” he says. “In the past, multiple devices that I’ve been known to use – even the most up-to-date one – we still have jams on certain biopsies. This one was a champion. It really took a great sample and I didn’t observe any signs of struggling with the biopsies.”
That’s music to Alameddine’s ears. “BD EleVation™ Breast Biopsy System comes from ‘elegant innovation.’ That’s how we got the name, and this really describes our solution very well,” she says. “When we consider developing products, it’s about reliable performance. We’re always seeking to help facilitate efficient procedures, and we also want versatile usability that serves many people – not just one specific profile or type of physician or patient,” she adds. “We think of the patient in every single moment of our process, of our programs, of our projects,” she says. “In every single thing that we do, we take into account, ‘OK, what does this translate into for a patient?’” When the first person in the U.S. had a biopsy taken with BD EleVation™ Breast Biopsy System after its launch, the oncology team got to see the gratifying fruits of their labor.
The BD EleVation™ Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities. The BD EleVation™ Breast Biopsy System is for diagnostic use only, NOT for therapeutic use. The BD EleVation™ Breast Biopsy System is contraindicated for those patients where, in the physician’s judgment, there is an increased risk of complications associated with percutaneous removal of tissue samples. Please consult product labels and inserts for complete indications, contraindications, hazards, warnings, precautions and directions for use.
© 2020 BD. BD, the BD logo, EleVation and SIMS are trademarks of Becton, Dickinson and Company or its affiliates. All Rights Reserved. BD-22127