Clinical and Industry News

FDA Clears New Blood Clot Aspiration System: Aspire Max

On February 28, 2012, Control Medical Technology announced receipt of United States Food and Drug Administration (FDA) clearance to market the Aspire Max Thrombus Aspiration System.

The patented Aspire Max Thrombus Aspiration System bridges the gap between basic syringe-catheter kits and complex systems. The core Aspire Aspirator is a high-performance aspirator with integrated handles and valves that allows clinicians to instantly create, increase, decrease, slow, stop, or “pulse” aspiration force. Max Thrombus Aspiration Catheters are proprietary large lumen aspiration catheters available in multiple outer diameters and lengths to improve aspiration speed, force, and control.

Blood clot size, anatomical location, and age can affect procedural success. Aspirating thrombus during a heart attack, stroke, or pulmonary embolism can save lives. Aspirating blood clots from vessels in the peripheral vasculature can reduce pain, promote healing, prevent amputation, and also save lives. Medical devices used to remove thrombus range from basic syringe-catheter kits to complex electromechanical catheter systems.

Basic syringe-catheters kits are effective with some thrombus, but lack power, anti-reinjection safety features, and do not give the physician the ability to instantly increase, decrease, pulse, or control aspiration force. Electromechanical systems can be powerful, but lack simplicity and global availability.

Shawn Fojtik, CEO of Control Medical, said, “Clinicians describe the Aspire as an ‘Aspiration Gas Pedal’ that allows them to control aspiration.”

The FDA clearance allows Control Medical to market the Aspire Max Thrombus Aspiration Catheter System including an Aspire Aspirator and a Max Catheter in one package, and/or Max Aspiration Catheters alone in multiple sizes, with an indication to remove soft, fresh thrombi and emboli, from vessels in the peripheral vasculature.

“Blood clots vary from acute, fresh, and soft thrombus to chronic, old, and organized clots,” continued Fojtik. “There is no ‘one-size-fits-all’ technology to remove thrombus. Too often, medical device innovation results in complicated and expensive devices. We want to innovate simple, safe, and high-performance technologies that work better than basic technologies but are easier to use and cost less than complicated alternatives.”

Control Medical Technology (www.aspirationmedical.com) is headquartered in Park City, Utah. The Aspire Max Thrombus Aspiration System, Aspire Aspirator, and Max Aspiration Catheters are made in the United States.

Boston Scientific to Acquire Cameron Health, Inc.

Company gains first and only commercially available subcutaneous ICD technology to offer lifesaving therapy to patients at risk of sudden cardiac arrest

Boston Scientific Corporation announces the exercise of its option to acquire Cameron Health, Inc., a privately held company based in San Clemente, California. Cameron Health has developed a subcutaneous implantable cardioverter defibrillator – the S-ICD^® System. Unlike conventional implantable cardioverter defibrillators (ICDs), which require thin, insulated leads to pass through the venous system and into the heart, the entire S-ICD System sits just below the skin and leaves the heart and blood vessels untouched.

The S-ICD System has received CE Mark and has been commercially available in select geographies, including several major European countries, since 2009. The system has been clinically evaluated in a variety of studies and has been implanted in more than 1,000 patients worldwide. Cameron Health received expedited review status and submitted its PMA application to the U.S. Food and Drug Administration (FDA) in December 2011. Boston Scientific anticipates FDA approval for the S-ICD System in the first half of 2013.

Hank Kucheman, Chief Executive Officer of Boston Scientific, said, “We expect that the S-ICD System, combined with recent ICD and CRT-D launches, upcoming pacemaker launches, and the recently acquired Watchman^® left atrial appendage closure device, will create a compelling and highly differentiated portfolio of arrhythmia management products.”

“The S-ICD System represents a new category of rhythm management devices that is unlike anything available today,” said Kenneth A. Ellenbogen, MD, FACC, Professor of Medicine and Director of the Electrophysiology Laboratory at the Medical College of Virginia. “This system provides physicians with a new alternative in the treatment of patients at risk for sudden cardiac arrest and should become first-line therapy for patients who may benefit from not having a lead in the heart.”

“The S-ICD System was designed to eliminate the complications associated with transvenous leads, creating an important new treatment option for patients at risk of sudden cardiac arrest,” said Kevin Hykes, President and CEO of Cameron Health.

Closing of the transaction is subject to customary conditions, including relevant antitrust clearance, and is expected to occur in the second or third quarter of 2012.

The S-ICD^® System is restricted under Federal law for investigational use only and is not for sale in the U.S.