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RAQA NEWS ROUND UP - (wc 08.04.19)

RAQA new medtech medical devices regulatory CE Mark Approved FDA

RAQA NEWS ROUND UP - (wc 08.04.19)

Saturated oxygen treatment for heart attack wins FDA approval

A new option for treating heart attacks has been awarded approval by the FDA. Currently, left anterior descending ST-elevation myocardial infarctions (LAD STEMI), the most serious type of heart attack, are typically treated by placing a stent in the narrowed artery, or percutaneous coronary intervention (PCI)

Now, a method developed by Irvine, California based company TherOx allows a catheter-based device to administer SuperSaturated Oxygen (SSO2) directly to the heart immediately after stenting (PCI) takes place.

In clinical trials, patients who received the oxygen treatment showed 26% infarct size reduction compared to those who only received PCI.

“Even after angioplasty with stenting, many heart attack patients suffer from irreversible damage to the heart muscle, which carries a poor prognosis in terms of mortality and the potential for future heart failure,” said Gregg W. Stone, M.D., professor of medicine, Columbia University Medical Center, in a TherOx announcement. “SuperSaturated Oxygen is the only therapy shown in a pivotal randomized trial to reduce infarct size in patients with large anterior myocardial infarction, offering the potential to further improve outcomes in these high-risk patients despite successful primary angioplasty.”

FDA Breakthrough Device Designation for CSA Medical RejuvenAir System

The RejuvenAir system designed by Lexington Massachusetts-based company, CSA Medical, has received breakthrough device designation from the FDA.

The device, for use in the treatment of moderate to severe chronic obstructive pulmonary disease (COPD) and chronic bronchitis, has a metered cryospray that sprays liquid nitrogen at -320° Fahrenheit (-196° Celsius) onto targeted areas in the lungs.

“We are especially encouraged that the FDA approved the IDE unconditionally,” said Wendelin Maners, CSA Medical’s President. “The study approval and device designation will allow us to greatly impact the lives of Chronic Bronchitis patients worldwide and collect significant clinical data surrounding our novel system.”

The device has also received investigational device exemption approval which will allow the company to proceed with a pivotal study.

ClearGuard HD Caps Cleared in Europe to Prevent Dialysis Infections

Pursuit Vascular's ClearGuard HD Antimicrobial Barrier Caps have been cleared for use in Europe, having received both CE Mark approval and Medical Device Single Audit Program (MDSAP) certificates.

The cap is the only device available that can kill infectious micro-organisms found within a catheter between dialysis treatments. There has been a 70% reduction in blood infections with patients that use the ClearGuard caps compared to those who use standard caps.

“The CE Mark and MDSAP approvals are significant accomplishments for Pursuit Vascular as it allows the company to expand sales to Europe and other key international markets,” said Doug Killion, president and CEO. “We look forward to working with hospitals and physicians in these countries to bring this lifesaving technology to more patients worldwide.”

“The extraordinary success of ClearGuard HD caps in the USA clearly demonstrates that we have been able to provide a highly effective product that is rapidly becoming the standard of care for dialysis treatment,” continued Killion.  “Pursuit Vascular is committed to creating technologies that aid in the prevention of catheter-related infection to enhance and extend the lives of patients around the world, and to reduce healthcare costs.”

FDA greenlights study of breakthrough device to treat aggressive pancreatic cancer

AngioDynamics has received FDA approval and investigational device designation to start its "Direct IRECancer Treatment" (DIRECT) clinical study of its NanoKnife Irreversible Electroporation device for the treatment of Stage 3 pancreatic cancer.

The device uses low level electrical pulses in order to open pores in target cell membranes, in turn, killing the cell. The treated tissue is then dispelled from the body using its own natural processes within weeks, imitating the natural death of a cell.

“The DIRECT study design demonstrates our commitment to provide an option that addresses a pressing unmet need for patients with Stage III pancreatic cancer,” said Jim Clemmer, President and Chief Executive Officer of AngioDynamics. “We are confident that our comprehensive approach, crafted through a constructive dialogue with the FDA, will generate meaningful data for clinicians, patients, payors and other stakeholders who are equally committed to fighting this disease, and we are dedicated to the idea that the standard of care for this deadly disease can—and should—improve.”

Part of the study will include a supporting website ( to support the enrolment of its participants. The site will provide information about pancreatic cancer and details of the study. It will also have a physician locator to help potential participants and clinical study locations.

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