Merit Medical's Embosphere Microspheres Gain FDA Indication for Prostatic Artery Embolization
June 22, 2017—Merit Medical Systems, Inc. announced that it has received 513(f)(2) (de novo) classification from the US Food and Drug Administration (FDA) to expand the indication for the company's Embosphere microspheres. The indication now includes prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH). Embosphere microspheres' indications for use also include embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
In 2013, Merit Medical announced European CE Mark approval to market Embosphere microspheres for embolization of the prostate gland for the relief of symptoms related to BPH. The PAE procedure uses Embosphere microspheres to selectively occlude the prostatic arteries, blocking blood flow to the prostate, resulting in reduced organ volume and reduced urethral stricture.
At that time, Merit Medical also announced that the FDA approved an investigational device exemption for the company’s international, multicenter, randomized clinical trial to compare the results of PAE to transurethral resection of the prostate for treatment of BPH. The company noted that clinical data demonstrated that patients achieve durable symptom relief while avoiding the complications and side effects associated with surgical or energy-based procedures and pharmacotherapy.
As summarized by the FDA, the Food and Drug Administration Modernization Act of 1997 added the de novo classification pathway under section 513(f)(2) of the Food, Drug, and Cosmetic (FD&C) Act, establishing an alternate pathway to classify new devices into Class I or II that had automatically been placed in Class III after receiving a Not Substantially Equivalent (NSE) determination in response to a 510(k) submission. The FDA explained, "In this process, a sponsor who receives an NSE determination may, within 30 days of receiving notice of the NSE determination, request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act. In 2012, section 513(f)(2) of the FD&C Act was amended by section 607 of the Food and Drug Administration Safety and Innovation Act, to provide a second option for de novo classification. In this second pathway, a sponsor who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act without first submitting a 510(k)."