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Perkasie, Pa. - Secant Medical officials have announced the availability of two diverse products that can advance the research and product development needs of medical device OEMs. The company is launching an off-the-shelf low-profile fabric for next-generation EVAR or heart valve component design and Regenerez, a research-grade resin for tissue engineering applications. Both products will be on display at MD&M West, Anaheim, Calif., at booth #1765 from Feb. 11-13, 2014.
“Available in eight different varieties, our woven low-profile fabrics offer clients an economical entrance into the market,” said Dan Treusch, business manager at Secant Medical. “Accessible through quick ship delivery, this product can help streamline our client’s development process.” Biocompatibility, low-permeability, high burst strength, and compaction for MIS delivery are a few of the features and benefits of the low-profile woven fabric.
Regenerez, a regenerative medicine platform
“Regenerez, our research-grade biomaterial, is a bioresorbable elastomer platform for regenerative medicine. It has tunable mechanical properties and enables healing without creating a harmful immune response,” said Dr. Josh Simon, business development manager at Secant Medical. “The material’s flexibility and inherent elastomeric properties offer limitless possibilities for tissue engineering in a variety of in vivo applications.”
Source: Secant Medical
Santa Clara, Calif. - The Kiva VCF Treatment System by Benvenue Medical Inc. received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the reduction and treatment of spinal fractures. The Kiva System is a novel implant-based solution for vertebral augmentation and a departure from balloon kyphoplasty (BKP), making it the first new approach to the treatment of vertebral compression fractures (VCFs) in over a decade. In the clinical studies provided in support of the 510(k) application for market clearance, the Kiva System was shown to meet or exceed the performance of BKP, the current standard of care in treating VCFs.
"Physicians and patients both benefit by having Kiva as a new, minimally invasive treatment option for painful VCFs. I'm excited to have been a part of KAST, an FDA-approved pivotal trial of the Kiva System, and I look forward to presenting the results at the Society for Interventional Radiology meeting in March," said Sean M. Tutton, MD, FSIR, co-principal investigator in the KAST Study (Kiva System as a Vertebral Augmentation Treatment – A Safety and Effectiveness Trial), and professor of radiology and surgery at the Medical College of Wisconsin in Milwaukee. KAST compared Kiva to the Medtronic KyphX System for balloon kyphoplasty.
VCFs occur when a vertebra (bone in the spine) cracks, fractures, or collapses. Curing the last 10 years, the approaches to treating VCFs have included conservative therapies or vertebral augmentation, traditionally performed with balloon kyphoplasty or vertebroplasty. The Kiva System features a proprietary, cylindrical implant made from PEEK-OPTIMA, representing a new approach to vertebral augmentation. The traditional approaches rely solely on a bolus of bone cement.
"We are excited to bring the Kiva System and its clinical benefits to the large and growing population of VCF patients in the US market," said Robert K. Weigle, CEO of Benvenue Medical Inc. "The VCF segment has little Level I clinical data, and we are proud to have sponsored one of the largest randomized studies in this space to date."
VCFs are most often caused by osteoporosis, and there are 700,000 osteoporosis-related vertebral compression fractures annually in the U.S. alone, representing a large patient population, which is only expected to continue growing as the population ages. Other causes of VCFs include trauma and malignant bone tumors that cause the spine to collapse.
About the Kiva VCF treatment system
The Kiva VCF Treatment System provides a new, implant-based approach to vertebral augmentation in the treatment of painful VCFs. It is indicated for use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.
The Kiva System features a proprietary flexible implant made from PEEK-OPTIMA, a biocompatible polymer that is widely used and well accepted as a spinal implant. The Kiva implant is designed to provide structural support to the vertebral body and a reservoir to direct and contain bone cement during vertebral augmentation. The implant is delivered percutaneously over a removable guidewire in a continuous loop into the vertebral body through a small diameter, single incision. The amount of the Kiva implant delivered is physician-customized during the procedure.
The Kiva System received CE Mark in 2008 and it is distributed by Zimmer Spine in Europe.
Source: Benvenue Medical Inc.
Pittsburgh - For the next 18 months, Carnegie Mellon University researchers will work with industry to develop methods to make the three-dimensional printing technology for fabricating metal components a higher volume manufacturing process.
With a $1.9 million grant from America Makes, the National Additive Manufacturing Institute in Youngstown, Ohio, CMU Mechanical Engineering Professor Jack Beuth will lead a research team in developing tools to improve powder-bed additive manufacturing processes, better known as 3-D printing. The technology allows the building of highly complex components that cannot be fabricated by traditional processes, while decreasing the cost of products, including jet engine parts and medical implants.
Beuth and CMU team members Fred Higgs, professor of mechanical engineering, and Anthony Rollett, professor of materials science and engineering, and Ola Harrysson of North Carolina State University, have been working to control and understand metal microstructure and mechanical properties of products made by two kinds of additive manufacturing processes. His team is investigating the EOS Laser Sintering process and the Arcam Electron Beam Melting process. Both are powder-based additive manufacturing processes that directly build metal components from metal powders. At present, these two additive manufacturing processes are the most successful at automatically fabricating any 3D shape of metals.
"At this time, high-quality results are only guaranteed if powders from the additive manufacturing machine manufacturers are used. For those processes to become high volume manufacturing processes, a wider range of powder options is needed," Beuth said.
Beuth's team is charged with determining how to alter the additive manufacturing process to allow for use of a wider range of powders. The team includes 12 industry partners representing powder manufacturing, aerospace, medical devices, electronics, and other industries. CMU, a founding member of America Makes, has purchased new metals-based additive manufacturing equipment to complete the research.
"We are looking to continue our dynamic partnerships with all participants as we seek ways to improve U.S. manufacturing," said CMU's Gary Fedder, director of the Institute for Complex Engineered Systems (ICES), associate dean of research for the College of Engineering and the university's leader in the ongoing additive manufacturing initiative.
Source: Carnegie Mellon
The new device, which was patented by researchers of the School of Industrial Engineering of the Universidad Politécnica de Madrid (UPM) in collaboration with the Universidad Autónoma de Madrid (UAM), has achieved minimizing the risks associated to emergency tracheotomies and the time needed to perform planned tracheotomies. This is possible because of a combination of mechanical and drilling devices with medical imaging elements and information management that will allow the adaptation of the surgery to the physical conditions of the patient.
This system can be applied to both adults and children and it allows localization of the patient's trachea quickly and effectively. In addition, the incision is performed automatically to create a fixed airway that can facilitate future surgeries.
The main functionalities of the new device are:
- Establishing neck position
- Identification of the tracheal air column
- An adequate patients data diagnosis
- Preload adjustment according to the shot aim
- Cut and incision to open an alternative airway
- Incision dilatation
- Maintenance of the airway with the support of electrical and air power
The design is currently in the development phase and is being assessed through the Medtronic Eureka platform.
In the future, apart from being used in surgery, the new tracheotomy device could become an element of public health security present in public places, the same as currently are present the defibrillators devices.
Source: Universidad Politécnica de Madrid