BD Introduces Nano Needle Technology to Improve Injection Comfort

Franklin Lakes, N.J.-based Becton Dickinson and Company (BD) has designed a line of ultra fine pen needles for diabetes patients who find it difficult to self-inject due to pain or fear. Studies suggest that as many as one-fifth to one-third of people with diabetes are hesitant or unwilling to give themselves insulin injections for reasons that include needle anxiety. Patients who reported injection-related pain or embarrassment also admitted they intentionally skipped insulin injections more often. A study by the American Association of Diabetes Educators (AADE) revealed that 47 percent of people with diabetes would be more likely to administer their injections regularly if a product were available that would ease the pain and discomfort of injections. With these needs in mind, BD Medical, a division of BD, developed the BD Ultra-Fine Nano Pen Needle with PentaPoint Comfort.

PentaPoint is a five-bevel needle tip designed to create a flatter, thinner surface to help penetrate the skin with significantly greater ease. In a clinical home-use study, patients who inject insulin found BD’s five-bevel pen needles to be significantly less painful, easier to insert, more comfortable and preferred overall when compared with current three-bevel pen needles. Bench tests showed the modified PentaPoint needle tip reduces the force to penetrate the skin by 23 percent compared to three-bevel pen needles.

In recent years, advances in needle manufacturing technology, along with shorter and thinner needles, have been associated with progressively improving patient self-rating of injection comfort. BD claims that its Ultra-Fine Nano is the shortest, thinnest pen needle available at 4 mm by 32 gauge. The needle has been clinically demonstrated to enhance comfort, and provides a less intimidating injection experience. The Nano also may help improve adherence to diabetes therapy regimens to support better health outcomes, company officials report. PentaPoint Comfort was added to the Nano needle to further advance patient comfort.

The 4 mm by 32 gauge BD Ultra-Fine Nano Pen Needle with PentaPoint Comfort. Photo courtesy of Becton Dickinson and Company.

“We are excited to provide another first-to-market innovation, designed to dramatically improve the injection experience for the millions of people living with diabetes,” said Linda Tharby, president of BD Medical—Diabetes Care. “Building on the introduction of BD’s smallest needle, the BD Nano, we are confident that our new, patented PentaPoint Comfort technology will provide an even more comfortable injection experience. This will help enable patients to adopt and adhere more easily to the therapy regimens recommended to improve their outcomes.”

AADE publication Diabetes Educator featured an article in 2011 which recommended injection technique strategies that encourage the use of the smallest possible needle for improved patient comfort and insulin efficacy. The BD Nano 4 mm Pen Needle reportedly is proven to be as effective as longer needles for patients of various body types and provides equivalent glucose control by effectively delivering the insulin dose to subcutaneous tissue (the layer of fat below the skin), the recommended site for insulin injections, and reducing the risk of injecting into muscle. Intramuscular injection can accelerate insulin absorption and increase the risk of unanticipated hypoglycemia (abnormally low blood sugar). Subcutaneous injection allows the insulin to be absorbed at an appropriate rate, resulting in better glycemic control.

Diabetes, a disease characterized by the body’s inability to regulate insulin, has become a national health concern in the United States, with an estimated 26 million people—8.3 percent of the population—living with the disease. Of those people, an estimated 18.8 million have been diagnosed with diabetes, and another 7 million are thought to be undiagnosed. According to a Population Health Metrics report, if current trends continue, as many as one in three U.S. adults will have diabetes by 2050. The total annual cost of diagnosed diabetes in the United States is an estimated $174 billion.
BD manufactures and sells medical devices, instrument systems, and reagents. It operates facilities worldwide.

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FDA Approves Ultrasound Companion to Mammograms
In April this year, the U.S. Food and Drug Administration (FDA) Radiological Devices Panel of the Medical Devices Advisory Committee recommended approval of U-Systems Inc.’s Somo-V Automated Breast Ultrasound (ABUS) system. The ultrasound system now has been approved by the FDA for use in women with dense breast tissue.

The Somo-V Automated Breast Ultrasound system. Photo courtesy of U-Systems Inc.

According to Ron Ho, president and CEO of the device manufacturer, at least 40 percent of women in the United States have dense breast tissue.

The ABUS system is meant to be used alongside a standard mammography in women with a negative mammogram and no breast cancer symptoms. According to the FDA, the transducer on the device is able to scan the entire breast in approximately one minute, producing several images for review.

Women who have had a previous breast intervention such as surgery or biopsy generally would not be eligible for screening with the device, the agency wrote, “since this might alter the appearance of breast tissue in an ultrasound image.”

It is the only ultrasound device approved for breast cancer screening in the United States, Canada and 27 European Union countries as an adjunct to mammography for asymptomatic women with dense breast tissue, U-Systems claims.

Dense breast tissue not only increases the risk of breast cancer up to four to six times but also makes cancer more difficult to detect using mammography, according to multiple large studies. One study, published in the New England Journal of Medicine, showed 35 percent of breast cancer goes undetected by mammography in women with dense breasts, as density masks the appearance of tumors.

“Enabling radiologists to use the information obtained from mammography and integrate that with the information obtained with ultrasound leverages the potential of ABUS in a screening environment to find the 30 percent additional cancers that would not have been found with mammography alone,” said Ho. “Research shows that ABUS can help find cancer in women with dense breasts, and that the cancers are smaller and early stage. With formal approval, we are moving rapidly from development to commercialization and look forward to making the Somo-V ABUS system more widely available across the United States.”

The FDA is requiring that U-Systems conduct training for clinicians and technology specialists who will use the device. The company also must distribute a manual that describes quality control tests that users should perform regularly.

U-Systems manufactures and markets ultrasound technology geared toward early cancer detection.
The company is based in Sunnyvale, Calif.

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Abiomed Updates Heart Pump
Danvers, Mass.-based Abiomed Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new heart pump, Impella CP (cardiac power). It is a more powerful version of the company’s Impella 2.5, delivering four liters of blood per minute rather than 2.5 liters for patients who have had heart attacks or are undergoing stent procedures.

The Impella CP. Photo courtesy of Abiomed Inc.

The device is meant to be used only for short periods. The increased flow is delivered on the same console platform—9 French catheter—and introducer as the Impella 2.5. Both of the Abiomed pumps reportedly are smaller than competing devices and are inserted through the leg by interventional cardiologists in catheterization labs. The company claims this technology is favored by many doctors over the surgical “cutdowns” through the shoulder used to insert other heart pumps. The Impella pump enters the body through the femoral artery, which feeds into the aorta. From there, the pumps hook into the left ventricle of the heart, redirecting the blood to the aorta, and pumping it into the rest of the patient’s body.

“The clinical community has been anxiously anticipating the arrival of this new Impella pump,” said John Lasala,­­­ M.D., medical director of Washington University School of Medicine in St. Louis, Missouri. “The Impella CP promises a substantial amount of cardiac power, can be inserted quickly, and is ideal for patients that require more hemodynamic support. It is exciting for physicians to be able to provide this type of percutaneous support that represents approximately 80 percent of what a healthy heart can pump each minute.”

“We are very pleased to announce the availability of the new Impella CP and we expect this to be a significant tool in helping more patients,” said Michael R. Minogue, chairman, president and CEO of Abiomed.

Impella CP’s clearance from the FDA was based on its substantial equivalence to the Impella 2.5. The device received CE Mark approval to market the device in Europe in April this year.

Greg Simpson, medical device analyst and senior vice president at investment firm Wunderlich Securities Inc. in Memphis, Tenn., told The Boston Globe that the product is a “game changer.” He also said it can be expected to boost Abiomed’s share in the more than $1 billion-a-year U.S. market for heart pumps as more physicians move away from balloon pumps. Balloon pump procedures usually are more invasive.

“Abiomed keeps expanding and extending the product line,” Simpson said. “And by raising the blood flow, the Impella CP provides doctors with an option to treat more patients who previously had to use more invasive devices or older devices in the market.”

Abiomed provides devices for circulatory support. The company has three FDA studies—Protect I, Recover I, and Protect II—currently published on Impella.