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

January 16th – January 22nd

January 18th: ZOLL Receives Marketing Clearance for E Series with Real CPR Help Technology.

ZOLL Medical Corporation (NASDAQ: ZOLL ), a manufacturer of resuscitation devices and related software solutions, today announced that it received clearance from the U.S. Food and Drug Administration (FDA) to market and sell the ZOLL E Series® with Real CPR Help(TM) technology. ZOLL's Real CPR Help allows rescuers to instantly see and hear how well they are performing the rate and depth of CPR chest compressions. With this clearance, the E Series becomes ZOLL's first advanced pre-hospital device to provide this instantaneous feedback.

All cardiac arrest victims need immediate and effective CPR. Furthermore, less than half of these victims require defibrillation initially since they are experiencing heart rhythms that are not "shockable;" that is, defibrillation will not help these victims' hearts beat normally again. The critical action is CPR, which achieves minimal but effective blood flow to feed oxygen to the heart and brain. CPR is also associated with a return of a "shockable" heart rhythm, making defibrillation possible later in the resuscitation event.

Sudden cardiac arrest (SCA) is an abrupt disruption of the heart's function, which causes a lack of blood flow to vital organs. This lack of blood flow can result in the loss of blood pressure, pulse, and consciousness. SCA is the leading cause of unexpected death in the world and strikes without warning. In the U.S. alone, there are more than 460,000 deaths each year from out-of-hospital cardiac arrest. Currently, only about 6 percent of victims survive.

January 18th: Carl Zeiss Meditec Announces FDA Clearance to Market VISUMAX Femtosecond Laser System.

Carl Zeiss Meditec, Inc. (CZM) reported that it has received U.S. Food & Drug Administration (FDA) clearance to market the laser keratome applications of its VISUMAX femtosecond laser system. The company had previously projected that this clearance would be granted in the second half of 2007, and the more rapid achievement of this process is an important and welcomed milestone for the company.

The VISUMAX system is designed to provide smooth and precise flap cutting capabilities for refractive laser surgery. This technology, combined with CZM's MEL 80 excimer laser, delivers excellent clinical outcomes coupled with the potential for a unique optimized work flow for refractive surgeons and improved comfort for their patients. Using a unique pivoting patient bed and an integrated data management system, the refractive surgeon will be able to complete a full refractive procedure without the need to move the patient or to perform redundant data entries. Alternatively, either platform may be used separately and/or in conjunction with other laser systems, but without the full system integration benefits.

Both MEL 80 and VISUMAX technologies were recently displayed and demonstrated at the American Academy of Ophthalmology (AAO) in Las Vegas. The MEL 80 is an advanced refractive laser system that has been marketed outside the U.S. since 2002. The MEL 80 recently gained FDA clearance for sale in the U.S., and the related clinical trials showed that 93 percent of patients were corrected to 20/20 or better visual acuity, with 41 percent achieving 20/12.5 or better at six months. With the subsequent FDA clearance of the VISUMAX femtosecond platform, the company is now positioned to more fully exploit the technology advantages and clinical benefits of its full refractive laser portfolio.

A commercial launch of the femtosecond technology is planned for mid-2007.

January 18th: Abbott to Sell Its Core Laboratory Diagnostics Business, Including Point Of Care, To GE For $8.13 Billion

Abbott (NYSE: ABT ) today announced that it will sell its core laboratory diagnostics business included in the Abbott Diagnostics Division and Abbott Point of Care (formerly known as i-STAT) to GE for $8.13 billion in cash, resulting in approximately $6 billion in after-tax proceeds. Abbott's Molecular Diagnostics and Diabetes Care (glucose monitoring) businesses are not part of the transaction and will remain part of Abbott.

Over the past several years, Abbott has made a number of acquisitions and completed other strategic actions that have transformed the company and positioned it for higher growth by strengthening the mix of its medical and pharmaceutical portfolio toward innovation and technology-driven businesses in emerging therapeutic areas. These include: Knoll Pharmaceuticals in 2001, TheraSense (blood glucose monitoring) in 2004, and Guidant's vascular business and Kos Pharmaceuticals (a leader in lipid management medicines), both in 2006. Additionally, Abbott spun off its hospital products business into a separate NYSE-traded company named Hospira in 2004.

"The laboratory diagnostics market has changed considerably in the last decade. Innovation in this segment will be increasingly driven by automation, system integration and a host of skills that GE can offer," said Miles D. White, chairman and chief executive officer, Abbott. "As part of GE, Abbott's core diagnostics and point-of-care businesses will be powerfully positioned to sustain and extend their market success."

The sale of Abbott's core laboratory diagnostics business to GE is expected to close in the first half of 2007 and is subject to customary closing conditions, including regulatory approvals.

The transaction is expected to be neutral to Abbott earnings per share in 2007, excluding specified items, and accretive thereafter.

January 22nd: Vascular Solutions Announces 510(K) Clearance of New 023 Version of the Twin- Pass Dual Access Catheter

Vascular Solutions, Inc. (Nasdaq: VASC ) today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration to launch the new 023 version of its Twin- Pass® dual access catheter. The original Twin-Pass catheter was launched in January 2006 as a two lumen catheter designed to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral arterial vasculature. The new 023 version features a larger 0.023" lumen that allows the Twin-Pass 023 catheter to measure intra-arterial pressures and deliver specialty guidewires into the distal vasculature. Vascular Solutions plans to launch the Twin-Pass 023 catheter through its direct U.S. sales force immediately.

Vascular Solutions is a medical device company focusing on developing unique solutions for unmet clinical opportunities within interventional radiology and interventional cardiology. New products introduced since the second half of 2003 include the Vari-Lase® endovenous laser product line for the treatment of varicose veins, the D-Stat Dry(TM) hemostatic bandage for the rapid control of topical bleeding, the Pronto(TM) extraction catheter for the aspiration of soft thrombus, the Langston® dual lumen catheter for the measurement of aortic stenosis and the Skyway® catheter for guidewire support and exchange.

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