A new treatment for a deadly form of brain cancer has been approved by the FDA and is cleared for sale in the U.S. market.
The NovoTTF-100A System (NovoTTF) made by NovoCure is a “non-invasive device consisting of four sets of insulated electrodes attached to an electronic box,” according to the privately-held Israeli company.
The FDA’s neurological devices panel last month voted 7-to-3, with 2 abstentions, that there is reasonable assurance that the benefits of the device outweigh its risks when “administered as a monotherapy in place of standard medical therapy” for treatment of for treating the brain cancer glioblastoma multiforme (GBM), according to a prepared release from the company.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
About 19,000 people in the United States are diagnosed with brain cancers every year, according to the National Cancer Institute. In 2010, more than 13,000 people died from brain and other nervous system cancers in the United States. GBM is the most common primary brain cancer and the tumor is highly resistant to standard treatments such as surgery, radiation and chemotherapy, according to the FDA.
On March 16 an FDA reviewers’ document posted on the agency’s web site said that clinical trials of the devices failed to show a significant increase in the overall survivability rate when measured against chemotherapy, but did significantly improve quality of life when compared to aggressive forms of chemotherapy.
The company, which was founded in 2000 by Yoram Palti, counts New York-based venture capital firm WFD Ventures as a primary investor in the company. The company has been conducting a Phase III clinical trial of the device since June 2009. That trial is expected to be completed in October 2012.
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.
