biomaterial implant News
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Healionics Awarded SBIR Contract from DOD to Develop Biointegrated Synthetic Vascular Graft
Healionics Corporation has been awarded a $150,000 Small Business Innovation Research (SBIR) contract from the Department of Defense (DOD) to demonstrate feasibility for an improved vascular graft design. Andrew Marshall, PhD, Healionics’ Chief Technology Officer, is the Principal Investigator for this research project. Titled, “Biointegrated Synthetic Grafts for Vascular ...
By Healionics
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Second Patent Issued for Healionics’ Textured STAR Biointerface
Healionics Corporation has received a further patent for its textured STAR Biointerface technology. The United States Patent and Trademark Office issued Patent No. 8,647,393, "Implantable Medical Devices Having Microporous Surface Layers and Method for Reducing Foreign Body Response to the Same.” This new patent extends the scope of 8,372,423 issued to Healionics in February 2013. The STAR ...
By Healionics
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Healionics Receives SBIR Grant from National Institutes of Health to Develop Needle Free Dialysis Access Devices
Healionics Corporation has received a $224,500 Small Business Innovation Research (SBIR) grant award from the National Institute of Diabetes and Digestive and Kidney Diseases division of the National Institutes of Health (NIH) for preclinical studies to develop a novel vascular graft for use with needle-free hemodialysis access ports. Andrew Marshall, PhD, Healionics’ Chief Technology ...
By Healionics
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Healionics’ Vascular Access Device Featured at American Society of Nephrology’s Kidney Week 2016
Healionics’ STARport HD, a novel preclinical stage implantable device that allows needle-free bloodstream access for hemodialysis treatment, has been selected by the American Society of Nephrology (ASN) to be featured at the ASN exhibit booth at Kidney Week 2016 as one of several new technologies portraying the future of kidney disease treatment. Kidney Week 2016 is the 50th annual kidney ...
By Healionics
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Healionics Announces New CEO
Healionics Corporation, a Seattle-based medical device company, today announced the appointment of Mike Connolly as Chief Executive Officer. Connolly brings 25 years of leadership in the medical device industry including extensive experience in both operating and venture investing roles. “We are fortunate to add a leader of Mike’s caliber,” said Andrew Marshall, Director and ...
By Healionics
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Healionics Awarded $1.5M SBIR Grant from NIH to Advance Clot-Resistant Synthetic Vascular Graft for Dialysis Patients
Healionics Corporation, a Seattle-based medical device company, was awarded a $1.5M Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) to develop new vascular grafts for dialysis use that overcome the major problem of clotting failure. Andrew Marshall, Ph.D., ...
By Healionics
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ASTM F2066 - 11 standard specification for wrought titanium-15 molybdenum alloy for surgical implant applications (UNS R58150)
This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-15 molybdenum alloy to be used in the manufacture of surgical implants. The product shall be classified as: strip; sheet; plate; ...
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RevBio Receives Approval from the U.K.’s Regulatory Authority to Initiate a Clinical Trial for an Optimized Formulation of its Dental Bone Adhesive Biomaterial
RevBio, Inc., announced that it has received approval from the Medicines and Healthcare products Regulatory Agency in the United Kingdom to start a 15-patient clinical trial to examine the safety and efficacy of immediately stabilized dental implants following tooth extractions using an optimized formulation of Tetranite®, the company’s bone adhesive biomaterial. Dr. Michael R. Norton, ...
By RevBio Inc.
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LaunchPad Medical Initiates its First European Clinical Study
LaunchPad Medical, Inc. announced that it has received approval from the Medicines and Healthcare products Regulatory Agency in the United Kingdom to start a 15-patient pilot clinical study to examine the safety and efficacy of Tetranite, the company's bone adhesive biomaterial, to immediately stabilize dental implants following tooth extractions. This study will focus specifically on anterior ...
By RevBio Inc.
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ASTM F136 - 11 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (R56401) to be used in the manufacture of surgical implants. The products are classified into: strip, sheet, plate, bar, forging bar, and wire. The heat analysis shall conform to the ...
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ASTM F1378 - 12 Standard Specification for Shoulder Prostheses
This specification covers shoulder prostheses for total or hemiarthroplasty used to provide functioning articulation by employing glenoid and humeral components. The prostheses may be constrained, partially constrained, or unconstrained. Modular prostheses are included in this ...
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ASTM F755 - 99(2011) Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
This specification covers the raw material and final product requirements, and the associated test methods for the selection of porous high density and ultra high molecular weight polyethylenes intended for use in surgical implants. The porous polyethylene may be used as a free standing product or as a coating on a substrate in nonloaded ...
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ASTM F2042 - 00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
This guide is intended to provide guidance for the specification and selection of fabrication methods for silicones used in medical devices. It also provides guidance relative to testing that might be done to qualify lots of acceptable material, based on desired performance properties. Silicone manufacturers supplying material ...
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ASTM F2091 - 01(2012) Standard Specification for Acetabular Prostheses
This specification covers acetabular resurfacing devices used to provide a functioning articulation between the bones of the acetabulum and the femur. Acetabular prostheses included within the scope of this specification are intended for mechanical fixation between the prosthesis and host bone, by the use of bone cement ...
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ASTM F2083 - 11 Standard Specification for Total Knee Prosthesis
This specification covers total knee replacement (TKR) prostheses used to provide functioning articulation by employing femoral and tibial components, allowing a minimum of 110' of flexion to high flexion. Replaceable components of modular designs, for example, tibial articulating surfaces and all components labeled for or capable of being used with cement, regardless of ...
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