Research Pays Off As New Products Obtain FDA Permission

Wound-care firm Applied Tissue Technologies declared that it had won FDA permission of its negative-pressure wound treatment product, the Platform Wound Dressing (PWD). The second class system signifies the first-of-its-kind embossed harmful pressure wound treatment equipment for use without gauze or foam, according to the Hingham, Mass. Company.

The PWD is a permeable dressing with an integral adhesive base and an impermeable membrane, permanently embossed that combines the traditional functions of this negative-pressure wound treatment membrane and foam/gauze in now marketed negative-pressure component. After the negative-pressure pump is turned on, the embossed layer is pulled into direct contact with all geometries of the injury, eliminating the need for gauze or foam.

The space created between the embossments provides main channels for fluid and air while folding from the membrane form secondary channels which offer an equal division of negative pressure around the injury.

“The PWD represents a true innovation in wound healing technology,” stated Applied Tissue CEO Michael Broomhead in an organized report. “Our company is committed to novel research and developing new technologies in advanced wound care. We believe that the PWD with its embossed NPWT will have a major impact in healing patients’ wounds.”

Self-governing of the clearance, ATT has three continuous clinical experiments funded by the U.S. military to evaluate the PWD.

Additional FDA Approvals For The Following Advances

FDA permits Rebound Therapeutics’ minimally encroaching neurosurgical endoscope

Rebound Therapeutics has obtained FDA 510 (k) approval for its Aurora Surgiscope system, which it advertises as the first one-time usable neurosurgical endoscope.

The Aurora arrangement facilitates visualization, minimally invasive access, and lighting during neurosurgical operations, the Irvine, Calif.–based firm said yesterday.

“Our physician advisors specified that we enable the complete neurosurgical procedure, without reliance on any third-party component, to keep the procedure minimally invasive, simple and without expensive capital equipment,” Rebound CEO Jeffrey Valko said in a press release.

“A significant opportunity exists to decrease operating room setup time, eliminate the risk of infections from re-sterilizing reusable devices, and to reduce procedural cleanup and operating room turnaround time,” Valko said. “We’ve integrated state-of-the-art visualization and illumination technology into an easy to use the device, compatible with current operating room high definition flat panel displays.”

The Aurora Surgiscope system comprises two elements: There is a sterile, single-use, brain endoscope called the Aurora Surgiscope plus a non-sterile, reusable Image Control Box unit.

FDA explains Imperative Care’s Stroke Therapy Catheters

Stroke-Therapy New Imperative Care (Campbell, Calif.) announced it had gained FDA permission for the first line of access catheters.

It may be challenging to access brain blood vessels due to the brain’s extraordinarily complicated and twisted vascular composition. The catheters were created to provide intermediation treatments during minimally invasive neurovascular procedures for stroke, aneurysms, and other brain blood-vessel conditions, the company said.

Realizing the significant need to improve the standard of patient therapeutics in stroke, Imperative Care was created to become the comprehensive stroke company innovating across the entire continuum of care, stated Fred Khosravi, Imperative Care founding chairman, and CEO in a statement. “Our approach is informed by a unique clinical perspective, along with a keen appreciation that this underserved medical category requires a holistic commitment and focus on making better stroke treatment modalities available to more patients around the world.”

Imperative Care is your 21st company co-founded by Incept, a MedTech accelerator, and development firm.

Advanced Imaging modalities, healing technologies and clinical rigor in identifying the importance of time and intervention in stroke care have revolutionized its therapy,  said CSO, L. Nelson Hopkins, M.D., Jacobs Institute in Buffalo, N.Y and Imperative Care co-founder.

“All of these important advancements have underscored that, as in the treatment of acute myocardial infarctions, improved mechanical solutions to physically open the blocked brain artery will continue to offer clear advantages for improved stroke patient outcomes,” Hopkins said. “Stroke does not need to be a handicap or death sentence. With new technologies, more patients will have the ability to go back to normal lives after a stroke.”

Imperative Care said it’s also developing a pipeline of technology designed to help clinicians improve the effectiveness and rate of acute stroke therapy, with the objective of allowing better patient outcomes. The business’s near-term pipeline involves an aspiration therapy catheter intended to enable rapid clot removal.

CorMatrix Obtains FDA IDE support for Cor Tricuspid ECM Heart valve experiment

pediatric valve

CorMatrix Cardiovascular stated today it gained FDA investigational project release approval to establish an early feasibility study of its cardiac valve meant for treating pediatric patients with inherited heart valve disorder and patients with endocarditis.

The Atlanta-based company touted its Cor Tricuspid valve since the first cardiac valve of its type created with an extracellular matrix and stated that its CorMatrix ECM was used in over 220,000 cardiac implants.

“This important step for our patients and CorMatrix to create a valve that will mimic in all respects a normal valve is no easy task, but the technology and our ability to harness the regenerative potential continues to improve,” chief scientific & medical officer Dr. Robert Matheny said in an organized statement.

CorMatrix said the analysis is conducted at eight clinical centers and will include both pediatric and adult patients.

“The Cor Tricuspid ECM valve is the first seamless ECM cardiac valve approved by the FDA for an IDE safety and feasibility clinical trial for adult and pediatric patient applications. The Cor Tricuspid ECM valve joins a rapidly developing CorMatrix pipeline of next-generation ECM products and patient solutions,” President & CEO Edgar Rey stated in a media release.

In July 2016, CorMatrix stated that it got CE Mark permission in the European Union because of the CanGaroo ECM medical container for implanted cardiac devices.

envelope for implanted devices

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