Industry Insider News

New Pressure Ulcer/Injury International Clinical Practice Guideline Released    

The European Pressure Ulcer Advisory Panel (EPUAP), the National Pressure Injury Advisory Panel (NPIAP), and the Pan Pacific Pressure Injury Alliance (PPIAP) recently released the new Clinical Practice Guideline for Prevention and Treatment of Pressure Ulcers/Injuries. The organizations note the goal of the international collaboration was to develop evidence-based recommendations for the prevention and treatment of pressure injuries that could be used by health professionals throughout the world. An explicit scientific methodology has been used to identify and critically appraise all available research, according to a press release.

“EPUAP is pleased to part of this truly international collaboration,” stated Professor Dr. Dimitri Beeckman, EPUAP President. “The Guideline Governance Group (GGG) and all small working groups worked intensely at global level to summarize the evidence and to develop practical recommendations to support clinical practice for our patients. We are looking forward to seeing how these new guidelines will be implemented and how they will further support better patient care.” 

“The NPIAP is pleased to join our international partners, the EPUAP and PPPIA, in releasing this international guideline,” says Janet Cuddigan, PhD, RN, FAAN, President of NPIAP. “The guideline critically analyzes and summarizes a large body of international research to develop evidence-based clinical recommendations. The guideline bridges a critical gap by accelerating the translation of research into practice to improve patient outcomes.”

“The Pan Pacific Pressure Injury Alliance (PPPIA) is proud to have partnered with the NPIAP, EPUAP and the 14 international associate partner organizations in the development of the 2019 Prevention and Treatment of Pressure Ulcers/Injuries Clinical Practice Guideline and Quick Reference Guide,” says Keryln Carville, PPPIA Chair. “The International Guideline contains 114 evidence-based recommendations and 62 good practice statements and 20 quality indicators, which will facilitate translation of guideline evidence into clinical practice and ultimately improve care outcomes for individuals across all health settings.”

In addition, HMP, a leading healthcare event and education company, recently announced a strategic collaboration between its Symposium on Advanced Wound Care (SAWC) meeting and the NPIAP, the leading authority on pressure injury and prevention, to further enhance practical education for interdisciplinary wound care professionals.

In addition to NPIAP’s endorsement of the 33rd annual SAWC Spring/Wound Healing Society meeting, taking place May 13–17, 2020, in San Diego, California, the agreement focuses on the development of a hands-on, multi-modal pressure injury prevention and treatment workshop as part of the 2020 SAWC Spring scientific program, according to HMP. Supported by Cardinal Health, EHOB, Milliken Healthcare, and Mölnlycke, and featuring a separate but complementary lecture from expert presenters from the NPIAP, including Dr. Cuddigan and Joyce Pittman, PhD, RN, ANP-BC, FNP-BC, CWOCN, FAAN, the workshop will provide an update of the newly launched International Pressure Ulcer/Injury Prevention and Treatment Clinical Practice Guidelines and allow for hands-on practice focused on technologies that assess early tissue injury and support prevention and treatment. Participating clinicians will receive a complimentary copy of the new guidelines. 

To order a copy of the Clinical Practice Guideline and the Quick Reference Guideline, visit www.guidelinesales.com. 

MTF Biologics Releases Leneva^™ Allograft Adipose Matrix and SomaGen^™ Meshed Allograft Dermal Matrix

MTF Biologics is introducing Leneva^™ Allograft Adipose Matrix and SomaGen^™ Meshed Allograft Dermal Matrix to its line of wound care solutions. Developed to advance the treatment of complex surgical wounds, these first-to-market tissue forms aid in tissue reconstruction and wound closure by providing protective coverage and promoting tissue integration, according to the company.

 MTF notes Leneva is an all-natural, extracellular adipose matrix for various tissue reconstruction procedures. The company says the matrix supports the patient’s tissue reconstruction process, is provided hydrated to reduce procedural preparation time, and provides an extracellular adipose matrix that functions as a scaffold for patient cells to create new fat.

 MTF says Leneva is derived from donated human adipose, and is aseptically processed, which allows the final adipose matrix to maintain sterility and the structural integrity of the tissue. Leneva is free from residual lipid, cellular fragments and DNA content, and the company says it retains key matrix proteins including collagen IV and collagen VI, and is injected where native fat already exists to provide soft tissue augmentation and cell attachment and remodeling.  

 SomaGen Meshed is an acellular human reticular dermal allograft that supports the treatment of a variety of large and complex wounds, notes MTF Biologics. The company says it is the only allograft tissue comprised of meshed reticular dermis on the market. SomaGen expands up to 150% to accommodate wounds of various sizes, and the company calls it ideal for areas where skin has been taken to cover wounds on another part of the body. The allograft conforms and expands to the wound and topography to provide immediate coverage and aids in the healing of wounds by improving drainage, notes the company. MTF adds that SomaGen provides a scaffold for wound closure to allow a patient’s own cells to proliferate and repopulate the graft and facilitate integration.

 MTF adds that SomaGen’s unique, lattice-based slit design may also eliminate the need for autologous skin grafting and manual meshing equipment in the operating room, lowering costs and reducing procedure time. 

For more information, visit www.mtfbiologics.org. 

MolecuLight Receives FDA 510(k) Clearance, AMA Category lll CPT Code for Real-Time Fluorescence Wound Imaging

MolecuLight Inc., has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its i:X^® handheld fluorescence imaging device for use in the detection of wounds containing bacteria. This FDA 510(k) clearance is an expansion of the original de novo clearance for the MolecuLight i:X platform, granted in 2018. 

MolecuLight says the i:X enables real time point-of-care visualization of fluorescence in wounds and measures wounds and digitally records all images and area measurements. The i:X’s fluorescence image, when used in combination with clinical signs and symptoms (CSS), has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads of >10⁴ CFU/g (colony-forming units per gram) as compared to examination of CSS alone, according to MolecuLight. In addition to the 510(k), the MolecuLight i:X also has CE marking allowing for its sale in Europe and is approved by Health Canada for sale in Canada.

As part of the cleared 510(k) application, the company says results from a clinical trial consisting of 350 patients, 14 sites and 20 clinicians were submitted to the FDA. This clinical trial demonstrated a three-fold increase in both sensitivity and diagnostic odds ratio in the number of wounds detected as having a bacterial load of >10⁴ CFU/g by use of the MolecuLight i:X in combination with CSS over CSS alone

MolecuLight Inc. has also been informed by the American Medical Association (AMA) that the CPT^® Editorial Panel accepted the addition of new Category III codes 0X30T, 0X31T to report “wound bacterial localization and treatment” to enable a reimbursement pathway for point-of-care fluorescence wound imaging. The effective date is July 1, 2020. At that time a novel code excluding the “X” will be reported by the AMA when the final datafiles are distributed by the AMA, notes the company. 

Category III CPT Codes are temporary codes for emerging technologies and procedures that allow for specific data collection associated with the work and costs of the procedures, notes MolecuLight. Reimbursement for procedures reported with a Category III code is at the payer’s discretion. As these procedures become more commonly adopted and established, MolecuLight says it will continue to work with the AMA to move these codes from Category III to Category I CPT status.

NOTE: CPT is a registered trademark of the American Medical Association.

For more info, visit www.moleculight.com. 

CryoLife and Misonix Enter Into Distribution Agreement for NeoPatch  

CryoLife, Inc. recently announced that it has entered into an agreement whereby Misonix will have exclusive U.S. commercialization rights for CryoLife’s NeoPatch product to treat a broad range of indications outside of cardiac and vascular surgery.  

NeoPatch is a dehydrated and terminally sterilized chorioamniotic allograft derived from human placental membrane. It is prepared using a proprietary process that maintains intact, native-state amnion and chorion layers and high levels of bioactive compounds, while also yielding a strong, uniform and adherent allograft that is less brittle than other amniotic allografts. NeoPatch can be used in advanced wound care applications as a “skin substitute” for chronic wounds, such as diabetic foot ulcers and venous leg ulcers, in orthopedic applications as an anti-adhesion barrier and in a variety of other surgical applications such as nerve and tendon repair.

For more info, visit www.cryolife.com.