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September 19 – September 25 

September 19th: Boston Scientific Announces Market Launch of the First Less-Invasive, Unilateral Visualization System for Cardiac Surgical Ablation

Boston Scientific Corporation today announced the U.S. market launch of the FLEXView(TM) System for unilateral visualization and routing in microwave cardiac surgical ablation procedures. The technology was launched by Boston Scientific's Cardiac Surgery business, formerly part of Guidant, which the Company acquired in April 2006.

Microwave surgical ablation can be performed in combination with valve or coronary artery bypass surgeries or in minimally invasive, stand-alone procedures. The new FLEXView System enables physicians to perform stand-alone ablation procedures in a closed chest environment with direct visualization of the procedure at all times. Furthermore, the FLEXView System allows surgeons to perform a one-sided (unilateral) ablation procedure, thereby decreasing the invasiveness of the current procedure.

The FLEXView System is the first system designed specifically for less-invasive, unilateral procedures. Patients should recover faster and with less pain than with procedures that require rib spreading.

The FLEXView System is designed to provide a wide and clear view of the anatomy and the surgical site at all times during the closed chest procedure.
The FLEXView System, which includes specialized routing and retrieval tools, may reduce overall procedure time by 30 minutes or more.

The FLEXView System is designed to be used in conjunction with the FLEX 10® surgical ablation probe in minimally invasive thoracoscopic cardiac ablation procedures. Microwave surgical ablation is used to apply focused microwave energy to cardiac tissue. The FLEX Microwave Surgical Ablation System, which consists of a microwave generator and probe, has been used in more than 1,300 stand-alone thoracoscopic ablation procedures and approximately 12,000 associated procedures.

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.

September 20th: Medwave's Fusion(TM) Granted 510(k) Clearance by FDA

Medwave Inc. the innovator in sensor-based, non-invasive blood pressure measuring solutions, announced today that it has received clearance by the U.S. Food and Drug Administration (FDA) to market Fusion(TM), the first completely sensor-based blood pressure with vital signs options monitor.

Fusion is a non-invasive blood pressure measurement device, built around Medwave's core sensor-based blood pressure technology, which takes readings at the wrist. Medwave's core technology has been the subject of numerous independent clinical validation studies, and results have shown that accuracy is comparable to an invasive arterial catheter. Fusion takes Medwave's core technology one step further by incorporating proven, sensor-based pulse oxymetry by Nellcor and thermometry by Kendall (both operating companies of Tyco Healthcare Group LP), creating a complete, non-invasive, and vital signs solution.

The launch of Fusion(TM) follows on the heels of the recent launch of Primo®, a portable, handheld blood pressure monitor that is currently in use at hospitals and clinics nationwide. Medwave recently announced distribution agreements with Tri-anim and McKesson for Primo. Like Primo, Fusion's sensor- based technology means that it is highly accurate, and can monitor patients with 11-22cm wrist sizes.

Medwave, Inc. develops, manufactures and distributes sensor-based non- invasive blood pressure solutions. Medwave's suite of products is designed for use in hospitals, clinics, doctor's offices and almost anywhere blood pressure monitoring occurs.

September 21st: Spire Receives FDA Clearance to Market Nanocrystalline, Silver Coated, Long-Term Dialysis Catheters.

Spire Corporation today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market silver coated hemodialysis catheters. The nanocrystalline, lubricious silver coating may reduce bacterial colonization on the catheter for up to two months, as demonstrated in clinical testing. The coating will be offered on Spire's XpressO® and RetrO® silicone catheter lines under the tradenames XpressO Silver(TM) and RetrO Silver(TM); both are split-tip chronic dialysis catheters.

The coating is deposited by Ion Beam Assisted Deposition (IBAD), an advanced vacuum-based thin film deposition process. The process results in a unique nanocrystalline silver film, which exhibits very low silver elution rates and is consequently long-lasting. This same silver coating has been successfully applied to other medical devices, such as vascular grafts, where the coating has been shown to reduce bacterial attachment and biofilm formation of S. aureus bacteria while providing natural integration into the surrounding tissue.

Spire Corporation is a diversified technology company providing innovative biomedical devices, advanced medical device surface treatment processes, optoelectronic devices, and solar energy products, all based upon a common technology platform.

September 25th: Medtronic Announces FDA 510(k) Clearance of Next-Generation Export(R) XT Aspiration Catheter

Adding to its legacy of vascular aspiration catheter technology, Medtronic, Inc. today announced the U.S. Food and Drug Administration 510(k) clearance of the Export® XT Aspiration Catheter. The Export XT is a next-generation aspiration catheter designed for removal of dangerous embolic materials that can result during vascular intervention procedures. Since its introduction in 2001, the Export aspiration catheter has been used with more than 150,000 patients worldwide for the removal of embolic debris.

Based on the proprietary "full-wall variable braiding technology" found in the Medtronic Launcher® and Sherpa NX guide catheters, the Export XT aspiration catheter promotes optimal performance during cardiovascular interventions. Aspiration catheters are important because they allow physicians to remove, or "aspirate," dangerous foreign particles (embolic debris such as blood clots and fat globules) that may become dislodged in a blood vessel during interventional procedures.

The Export XT aspiration catheter features a soft tip material with a short, beveled design for minimal vessel trauma and improved debris capture, plus a hydrophilic coating for greater lubricity. The "full-wall variable braiding" also helps eliminate segment joints and weak points in the catheter to improve kink resistance, and allows enhanced deliverability due to seamless transition of shaft stiffness from one end of the catheter to the other.

Available immediately from Medtronic, the Export XT aspiration catheter is available in a length of 140 cm and is compatible with a 0.014-inch guidewire and a 6F guide catheter or sheath configuration.

Medtronic, Inc. headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

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