Home  | About mdi |  Services  | Industries | News & Information | Partners | Contact| Site Map

November 7th – November 13th

November 9th: BioSphere Medical Receives FDA Approval For QuadraSphere(TM) Microspheres

BioSphere Medical, Inc, a medical device company that pioneered the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations, today announced that the U.S. Food and Drug Administration has cleared the 510(k) notification for BioSphere's proprietary QuadraSphere(TM) Microspheres, permitting the sale of this product in the United States. U.S. shipments through BioSphere's direct sales force are expected to begin immediately.

BioSphere's QuadraSphere Microspheres ("QuadraSphere"), which are indicated to treat hypervascularized tumors and peripheral arteriovenous malformations, are delivered by interventional radiologists who perform embolization procedures. Embolization is an image-guided, minimally invasive therapy that selectively occludes the blood supply of benign or malignant hypervascularized tumors, including liver tumors. QuadraSphere is technically identical to BioSphere's HepaSphere(TM) Microspheres ("HepaSphere"), an embolic currently marketed in Europe.

QuadraSphere's technical attributes are designed to provide a unique and versatile embolization platform. Its spherical shape allows for a predictable, flow-directed occlusion. The product rapidly expands up to four times its dry-state diameter and thus absorbs aqueous media up to 64 times its dry-state volume. In addition to the absorption process, the negatively charged polymer is also capable of selective bonding with positively charged substances through ionic interaction. Also, QuadraSphere affords atraumatic conformability to the vessel architecture, leading to a more complete vessel occlusion.

November 9th: Cynosure Receives FDA Clearance for Smartlipo(TM) System

Cynosure, Inc. (Nasdaq: CYNO ), a leading developer and manufacturer of a broad array of light-based aesthetic treatment systems, today announced it has received clearance from the U.S. Food and Drug Administration for its Smartlipo(TM) system for laser assisted lipolysis, or LaserBodySculpting(SM), a procedure that disrupts fat cells and causes coagulation of the tissue leading to skin tightening. The Smartlipo system provides aesthetic surgeons a new, less- invasive method for reducing fat cells.

Cynosure believes the demand for liposuction and body sculpting procedures that remove or reduce fat cells is increasing. For example, nearly 500,000 liposuction procedures were performed in the U.S. in 2005, making it the number one surgical cosmetic procedure among both women and men according to the American Society for Aesthetic Plastic Surgery (ASAPS).

The LaserBodySculpting uses a small cannula, or tube, containing a laser fiber that is inserted into the skin and passed throughout the treatment area. The laser's energy is applied directly to the fat cells, causing them to rupture and drain away. Treatments with the Smartlipo system generally result in less swelling and bleeding as compared to traditional liposuction methods and can usually be performed in one 45-minute session.

Cynosure, Inc. develops and markets aesthetic treatment systems that are used by physicians and other practitioners to perform non-invasive procedures to remove hair, treat vascular lesions, rejuvenate skin through the treatment of shallow vascular and pigmented lesions and temporarily reduce the appearance of cellulite.

Home  | About mdi |  Services  | Industries | News & Information | Partners | Contact| Site Map