EMBA Medical may now market its peripheral embolisation device in New Zealand due to the successful completion of the WAND (Web Assisted Notification of Devices) notification. In addition, the company announced completion of enrolment and release of 30-day follow-up data for the 10-patient EMBA Peripheral Embolization Device (EPED) study conducted at Auckland Hospital.
EMBA Medical completed the notification for the device, known as the Hourglass peripheral embolisation plug, through the New Zealand WAND database in conjunction with in-country sponsor Emergo on 21 September, 2015.
George Wallace, chief executive officer of EMBA Medical, said, “This is the first integrated, over-the-wire device designed for peripheral embolisation procedures. We believe that the Hourglass device will provide a new level of confidence, precision, and control for physicians performing peripheral embolisation procedures.”
Interventional radiologist Andrew Cragg, co-inventor of the Hourglass device, commented, “The goal with over-the-wire design is to provide physicians with accurate, stent-like delivery of the device in the vessel. The device’s unique design was created to take advantage of natural haemodynamic forces to provide immediate, focal, stable occlusions.”
Patient interim results from the EPED study demonstrated the benefits of both the hourglass design and over-the-wire delivery including:
- 90–100% occlusion at one minute post-implant placement
- Trackability rated as “easy” in 10/10 procedures
- Pipeline embolisation device occlusion at completion rated as “complete” in 100% of cases
- Value of over-the-wire device placement rated as “very useful”.
Andrew Holden, director of Interventional Radiology at Auckland Hospital and associate professor of Radiology at Auckland University School of Medicine, is the primary investigator in the EPED clinical study. Following the first 10 cases with the 5F Hourglass plug, he commented, “We implanted the EMBA Hourglass in a variety of clinical embolisation procedures. We found that the device was superior to coil embolisation in many aspects including the ability to accurately deploy over a wire and obtain immediate occlusion with a single device in a wide range of vessel sizes.”
The Hourglass embolisation plug is a Class IIb medical device and is manufactured in the EMBA Medical ISO-certified manufacturing facility in Miramar, USA. The device was awarded a CE mark certificate in July 2015, enabling the company to pursue commercial activities in EU nations. The device has been submitted to the US Food and Drug Administration and is currently under review.