• Gen-Probe (San Diego) has submitted a PMA to the FDA for its Aptima HPV (human papillomavirus) assay, a new molecular test that detects high-risk HPV infections that are associated with cervical cancer and precancerous lesions. The Aptima HPV assay is an amplified nucleic acid test that detects 14 high-risk HPV types that are associated with cervical cancer. More specifically, the assay detects messenger RNA (mRNA) from two viral oncogenes, E6 and E7, which are more prevalent in the severe cervical lesions likely to progress to cervical cancer. Gen-Probe believes targeting E6/E7 mRNAs may more accurately identify women at higher risk of having, or developing, cervical cancer than competing assays that target HPV DNA.

• IDEV Technologies (Webster, Texas) reported the first procedure in the U.S. using the Supera Veritas transhepatic biliary system, which was recently cleared to market by the FDA. The Supera wire interwoven nitinol stent is cleared for palliative treatment of biliary strictures produced by malignant neoplasms. Biliary strictures involve a narrowing of the bile duct, the body's transportation system for fluid that is an essential aid to the digestion of food. Stents are commonly used to reopen the bile duct and restore the natural flow of fluids. Full commercial launch of the Supera Veritas Transhepatic Biliary system is planned for 1Q11.

• X-spine (Miamisburg, Ohio) reported FDA clearance of its new Axle interspinous fusion system. The system is designed to provide spinal stability for lumbar fusion procedures, including the treatment of degenerative disk disease, spinal tumors and trauma. The Axle system uses a modular design to allow for implant customization to conform to individual patient anatomy. The implant can be placed through a one inch incision in the back with minimal disruption of tissue. The device works by rigidly attaching to the rearmost portion of adjacent vertebrae, termed the spinous process, of the lower or middle spine.

No Comments