HeartWare International Inc. files a pre-market approval application with the Food & Drug Administration for a ventricular assist device designed as a bridge-to-transplant system.
HeartWare International Inc. (NSDQ:HTWR) filed a pre-market approval application with the Food & Drug Administration for its cardiac assist device.
The Framingham, Mass.-based company’s ventricular assist system is designed to provide a temporary “bridge” for heart transplant patients with “end-stage heart failure,” according to the company.
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MassDevice Staff Website The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
Patients implanted with the device in HeartWare’s Advance clinical trial had a 94 percent survival rate, according to the company.
The company closed a $143.8 million debt offering and investor Apple Tree Partners completed the sell-off of 1 million shares for more than $81 per share in December.
A PMA is a regulatory pathway to market medical devices that have no incumbent products with which the FDA can compare the safety.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
