Industry Insider News

FDA Approves New Treatment for DFUs

The U.S. Food and Drug Administration (FDA) has announced its approval for the marketing of what is being described as the first shock wave device intended to treat diabetic foot ulcers (DFUs) — the dermaPACE^® System. 

“Diabetes is the leading cause of lower-limb amputations,” said Binita Ashar, MD, director of the division of surgical devices in the FDA’s Center for Devices and Radiological Health. “The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases. Additional options for successfully treating and healing ulcer wounds may help prevent lower-limb amputations.”

According to FDA officials, the dermaPACE System is intended to be used in the treatment of chronic, full-thickness DFUs with wound areas measuring no larger than 16 cm² that extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The system is an external (extracorporeal) shock wave device that uses pulses of energy, similar to sound waves, to mechanically stimulate the wound. The device is intended for adult patients (22 years and older) presenting with DFUs lasting > 30 days, and should be used along with standard diabetic ulcer care, according to the FDA. The FDA reviewed clinical data from two multicenter, randomized, double-blind studies with a total of 336 patients receiving either usual care, which includes wet-to-dry dressings or debridement, as needed, plus the dermaPACE shock wave therapy, or usual care plus nonworking (sham) shock wave therapy. Both patient groups included those with poorly controlled and well-controlled blood glucose levels. The patients who had between one and seven treatments with dermaPACE showed an increase in wound healing at 24 weeks with a 44% wound closure rate. Those patients treated with the sham shock wave therapy showed a 30% wound closure rate during the same time period. The most common side effects observed were pain during application of the device, local bruising and numbness, migraines, nausea, fainting, wound infection, infection beyond the wound (cellulitis, osteomyelitis), and fever. dermaPACE was reviewed through the de novo premarket review pathway, a regulatory pathway for some low-to-moderate-risk devices of a new type for which there is no legally marketed predicate device to which the device can claim substantial equivalence. This action also creates a new regulatory classification that would allow future devices to go through the FDA’s 510(k) process, whereby devices can demonstrate substantial equivalence to this predicate device. The FDA permitted marketing of the dermaPACE System to Sanuwave^® Inc., Suwanee, GA. 

Report Ranks States’ Abilities to Emergency Prepare

A report by Trust for America’s Health (TFAH), a nonprofit, nonpartisan organization that focuses on disease prevention and best practices, ranks the country’s states on their level of emergency preparedness. 

Quality indicators included having an increased or sustainable amount of funds going to public-health initiatives, having an accredited health department, having 70% or more hospitals meeting Antibiotic Stewardship Program elements in 2016 (per the Centers for Disease Control and Prevention), and having a flu vaccination rate higher than 50%. The report, Ready or Not? 2017 Protecting the Public’s Health From Diseases, Disasters and Bioterrorism, used survey responses to calculative scores. Massachusetts scored best; Alaska fared worst.  Visit https://healthyamericans.org/assets/files/TFAH-2017-Ready
OrNot%20FINAL.pdf to access the full report. 

U.S. Life Expectancy Continues to Fall

The average life expectancy in the United States has fallen from what it was in 2015, according to the Center for Disease Control and Prevention's (CDC’s) National Center for Health Statistics. CDC officials say the changes are the first consecutive declines in life expectancy at birth since the early 1960s. Compared to 78.7 years in 2015, the average American lived to 78.6 years in 2016. In 2016, the decline in life expectancy was only for males (76.1 years in from 76.3 in 2015) while, for females, life expectancy remained the same at 81.1 years, according to the CDC. 

The 10 leading causes of death remained the same in 2016 as in 2015: heart disease, cancer, unintentional injuries, chronic lower respiratory diseases, stroke, Alzheimer’s disease, diabetes, influenza and pneumonia, kidney disease, and suicide. Visit www.cdc.gov/nchs/index.htm for the full report. 

AlloSource Names New Chief Financial Officer 

Raime Leeby Muhle has been named chief financial officer at AlloSource, Centennial, CO, a provider of cartilage, bone, skin, soft tissue, and cellular allografts for use in surgical procedures and wound care. Her background includes high-growth businesses and large, mature organizations, and Leeby Muhle has worked in a variety of industries, including technology, distribution, manufacturing, and telecommunications, according to company officials. Leeby Muhle is taking over for Olivia Thompson, who is transitioning into retirement to focus on project-based work.

“We are thrilled to welcome Raime to our executive team,” said Thomas Cycyota, AlloSource president and chief executive officer. “Her financial expertise and leadership, as well as her passion for our mission, will help drive AlloSource’s growth as we continue to evolve the advanced allograft therapies we provide for surgeons.”