dCELL® Technology removes more than 99% of DNA, leaving an intact extra cellular matrix.
Unlike alternative processes, dCELL® Technology results in greater than 99% DNA removal and produces decellularized biological tissue with virtually no structural disruption, thus providing an optimal replacement for the damaged extracellular matrix, allowing the patient’s living, native cells to populate and integrate ultimately achieving the goals of soft tissue healing and regeneration.
Dermapure has taken a leap forward, now available in pre-cut shapes with the VNEW®. This is a next generation decellularized dermal allograft for pelvic floor surgery, processed with dCELL® Technology.
The VNEW® Pre-cut Decellularized Dermal allograft is the new evolution of VNEW®, and a non-oriented dual dermis allograft available in two precut shapes: anterior and posterior.
VNEW® is intended to be used for the repair, replacement, or reconstruction of damaged or inadequate integumental
tissue in the pelvic floor, including gender affirmation procedures.
This evolution to the original Dermapure also provides supplemental support to soft tissue (ligament) repairs in anterior, posterior, and apical prolapse procedures.
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DermaPure® is a decellularized dermal tissue with virtually no structural disruption allowing tissue and cellular regeneration to occur. DermaPure® has been demonstrated to provide higher pro-angiogenic response during integration with reduced fibrosis.1,2
DermaPure® is available in three sizes:
3cm x 4cm, 4cm x 6cm, and 7cm x 10cm.
Reference:
Greaves NS, Iqbal SA, Morris J, et al. Acute cutaneous wounds treated with human decellularised dermis show enhanced angiogenesis during healing. PLOS ONE. 2015;10(1):e0113209. Greaves NS, Bayat A (2015). Skin Substitute-Assisted Repair Shows Reduced Dermal Fibrosis in Acute Human Wounds Validated Simultaneously by Histology and Optical Tomography. Wound Rep Reg (2015) 23 483–494
Retains collagens, proteoglycans, glycosaminoglycans, as well as other extracellular matrix proteins.
DermaPure® and VNEW® set itself apart from other tissue options and decellularization processes by using the unique and patented dCELL® Technology.
The result is lower immunogenicity because the decellularized donor tissue has nearly no structural disruption, with greater than 99% of the donor DNA removed.
References: 1. Greaves NS, Iqbal SA, Morris J, et al. Acute cutaneous wounds treated with human decellularised dermis show enhanced angiogenesis during healing. PLoS ONE. 2015;10(1):e0113209. 2. Greaves NS, Bayat A (2015). Skin Substitute-Assisted Repair Shows Reduced Dermal Fibrosis in Acute Human Wounds Validated Simultaneously by Histology and Optical Tomography. Wound Rep Reg (2015) 23 483–494 3. Data on file at Tissue Regenix Limited.
Flexibility: Suitable for abdominal, trans-vaginal and robotic surgery.
Enhanced angiogenesis and integration: DermaPure® exerted a higher quantity and quality of revascularization within 3 – 4 weeks and integrates with and closely approximates the structure and function of native tissue.1,2
Reduced fibrosis: Progressive colonization of DermaPure® by native cells results in expression of key genes that are associated with reduced inflammation.2
Reduces OR Time: Available in multiple sizes and precut shapes for posterior and anterior repair.
Safety: Provides a decellularized human tissue option, with an intact ECM, that is > 99% DNA free.
Ease of use: Optimizes graft handling and high suture pullout strength.
Video: Novel surgical approach incorporating DermaPure® with
the SSL and USL to address apical prolapse.
dCELL® Technology removes more than 99% of DNA, leaving an intact extra cellular matrix.
“Working closely with ARMS Medical as our provider of specialty pelvic floor surgical solutions, my team had the opportunity to use DermaPure allograft, along with the Veronikis Vaginal Retraction System. This solution allowed a minimally invasive vaginal approach for a positive surgical and patient outcome.”
— R. Keith Huffaker, MD, MBA, FACOG, FPMRS
Unlike alternative processes, dCELL® Technology results in greater than 99% DNA removal and produces decellularized biological tissue with virtually no structural disruption, thus providing an optimal replacement for the damaged extracellular matrix, allowing the patient’s living, native cells to populate and integrate ultimately achieving the goals of soft tissue healing and regeneration.
Unique vaginal dilator with graduated couplers enabling patient to self-adjust to maintain their vaginal length
A versatile and adjustable dilator based upon patient’s needs
Provides two different length bases for seated and nighttime dilation
Graduated couplers allowing conversion to different sizes
Variable dilator lengths available from 1.5 cm to 13 cm
Vaginal tightness
Painful intercourse due to pelvic floor dysfunction caused by (but not limited to) vaginal atrophy, vaginismus, vulvodinia, vulvar vestibulitis, interstitial cystitis, dyspareunia, vaginal narrowing and similar gynecological conditions
Vaginal discomfort following childbirth, post-surgical recovery or post radiation adhesions
The SEP for removal of smoke and liquid during electrocauterization captures up to 150 different chemicals during the procedure.
VNEW is an evolution of Dermapure, specifically designed as a pre-cut decellularized dermal allograft for pelvic floor repairs. While Dermapure offers a groundbreaking approach to tissue regeneration, VNEW enhances this with pre-cut shapes for anterior and posterior applications, leveraging advanced dCELL® Technology for even more precise and efficient surgical outcomes.
VNEW is intended for a broad range of pelvic floor repairs, including but not limited to the repair, replacement, or reconstruction of damaged or inadequate integumental tissue. This includes surgeries for anterior, posterior, and apical prolapse repairs, making it a versatile choice for addressing various pelvic floor conditions.
Yes, VNEW can be suitable for individuals who have undergone gender affirmation surgery and require pelvic floor repair or reconstruction. Its adaptability and the use of decellularized dermal allografts make it a potentially beneficial option for supporting soft tissue repairs in a wide array of surgical applications, including gender affirmation procedures.
The long-term benefits of VNEW include enhanced tissue integration, reduced risk of immune rejection, and improved surgical outcomes. Its advanced dCELL® Technology promotes natural tissue regeneration and healing, offering stronger, more flexible repairs that closely mimic natural human tissue behavior. This can lead to better durability, function, and overall quality of life post-surgery compared to traditional methods.
The recommended rest and recovery time after surgery using VNEW can vary depending on the individual’s overall health, the complexity of the surgery, and specific procedural details. Generally, VNEW is designed to enhance healing and potentially shorten recovery times thanks to its efficient integration with the patient’s own tissues. However, it’s crucial to follow personalized post-operative care instructions provided by your healthcare provider for the best outcomes.
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