Stryker Corp. (NYSE:SYK) received 510(k) clearance from the Food & Drug Administration for its new hip replacement system.
The clearance adds another product to the Kalamazoo, Mich.-based-medical device maker’s portfolio of orthopedic devices, which performed well through the recession.
The MDM X3, or "Modular Dual Mobility," mobile bearing hip system’s entrance to the market follows the company’s ADM X3 system, which launched about a year ago and proved to be a boon for the company’s orthopedics business.
Revenue from the Stryker’s knee and hip businesses rose about 6 percent in 2010 to $4.3 billion, despite strong headwinds and pricing pressures that copmany officials called a “perfect storm.”
The MDM X3 is the company’s third-generation "dual mobility" device and was designed to increase the technology’s applicability to a broader patient population, according to the company.
Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
- Cardiovascular Systems Files Special 510(k) for Stealth 360° Orbital Pad System
Cardiovascular Systems Inc. (CSI) (NSDQ:CSII), has filed a Special 510(k) application with the Food & Drug Administration. The application seeks marketing clearance for the Stealth 360° Orbital PAD System, a third-generation electric powered device for the treatment of peripheral arterial disease. The Stealth 360° system eliminates the large capital equipment portion of the current product for a more compact system. With simple, convenient speed adjustments on the handle, physicians can use lower speeds and have greater control during the procedure to achieve shorter spin times and a high percentage of plaque reduction.
- Orthovita Receives FDA Clearance for Vitoss Bimodal Bone Graft Substitute
Orthovita Inc. (NSDQ:VITA), an orthobiologics and biosurgery company, announced that it received 510(k) clearance from the Food & Drug Administration to market Vitoss BA Bimodal Bone Graft Substitute as a non-structural bone void filler for use in the extremities, pelvis and posterolateral spine. Vitoss Bimodal is anticipated to launch in the United States in 9-12 months after the introduction of Vitoss BA2X which will be commercially introduced by Orthovita next week at the 2011 Meeting of the American Academy of Orthopedic Surgeons. Vitoss BA Bimodal differs from previous versions of Vitoss BA by modifying the size distribution of the bioactive glass particles to accelerate resorption of the bioactive glass.
- RepRegen seeks US FDA 510(k) clearance for StronBone
RepRegen, the ‘smart biomaterials’ company, announced that RepRegen Inc. in the US has submitted StronBone to the FDA for 510(k) clearance. StronBone bioactive glass with Strontium is the first product that is being commercialized from RepRegen’s repair and regeneration platform of ‘smart’ biomaterials for bone and other (hard) tissue. Recently, RepRegen received CE Marking Approval for StronBone. RepRegen has discovered that the addition of Strontium ‘turbocharges’ the bioactivity of bioceramic technology; this major materials science discovery enables development of enhanced products to repair and regenerate bone and other (hard) tissue.
- miraDry by Miramar Labs Receives FDA 510(k) Clearance
Miramar Labs announced that it has received FDA 510(k) clearance for the new miraDry System for the treatment of primary axillary hyperhidrosis, commonly known as excessive underarm sweat. miraDry is a non-invasive, quick, outpatient procedure that provides a lasting solution for this debilitating condition. Primary axillary hyperhidrosis is a medical condition in which more underarm sweat is produced than is needed to cool the body. Millions of Americans suffer from excessive underarm sweat, and many suffer silently—ashamed, frustrated and embarrassed because excessive underarm sweat can interfere with nearly every aspect of life.
- Pervasis Receives FDA Fast Track Status for Vascugel to Prevent Arteriovenous Access Failure in Patients Undergoing Hemodialysis
Pervasis Therapeutics announced that the Food & Drug Administration has granted Fast Track review status for Vascugel for the prevention of hemodialysis access failure in patients with end stage renal disease (ESRD). Vascugel, a novel endothelial cell-based therapy and Pervasis’ lead development program, aims to regulate the body’s healing response following surgical interventions to create vascular access points which are necessary for ESRD patients undergoing hemodialysis, reducing the need for repeat surgical interventions and improving overall patient outcomes.