FDA Panel to Discuss Leadless Pacemaker
An FDA advisory committee will discuss clinical trials, postapproval study design and physician training requirements for leadless cardiac pacemaker device technology during a meeting in February. The Circulatory System Devices Panel will make recommendations on topics such as the acceptability of adverse event rates in acute and chronic timeframes as well as indications for use. The meeting is scheduled for Feb. 18. Read the Federal Register notice here: .
Medtronic to Open Ireland Facility
Medical device giant Medtronic has unveiled plans to open a new facility in Galway, Ireland to manufacture its IN.PACT Admiral drug-coated balloon for the treatment of peripheral artery disease. The decision to open the new facility was based on the existing high-tech capability and expertise at the site in drug-device combination products for the company’s coronary business, according to the Irish devicemaker. The facility — which will have 20,000 square feet of space with 8,000 square feet for manufacturing — will cost about $14.3 million.
Avita Scores FDA EAP Designation for ReCell
The FDA has granted Avita Medical’s ReCell expedited access pathway designation. ReCell enables a clinician to quickly create regenerative epithelial suspension — an autologous suspension comprising the cells and wound healing factors necessary to regenerate skin — with a small sample of the patient’s skin, in approximately 30 minutes. Avita has recruited 26 of the target 30 patients for the trial of the device that will take place at seven burn centers. The company estimates that ReCell will receive regulatory approval in the third quarter of 2017. It is currently CE marked in Europe, TGA-registered in Australia and CFDA-cleared in China.
Hoang Long to Distribute CytoSorb in Vietnam
Medical distributer Hoang Long Pharma has reached a multi-year agreement to distribute CytoSorbents’ CytoSorb extracorporeal cytokine adsorber in Vietnam. Financial terms of the agreement were not disclosed. Using blood purification to control deadly inflammation, CytoSorb works to reduce the “cytokine storm” that could cause massive inflammation, organ failure and death in critical illnesses such as sepsis, burn injury and trauma. The device is approved in the EU with distribution in 32 countries around the world.
Alimera Inks Pact With MEAgate
An Alimera Sciences unit has entered an agreement that will allow MEAgate International to distribute the ILUVIEN implant throughout the Middle East. Under the agreement, MEAgate will open a scientific office for Alimera in the Middle East to support regulatory, medical affairs, sales and marketing operations. The ILUVIEN implant — which has U.S. regulatory sign off for the treatment of diabetic macular edema — is designed to release submicrogram levels of fluocinolone acetonide for 36 months. Countries included in the agreement are Bahrain, Egypt, Iraq, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, the United Arab Emirates and Yemen. An estimated 16 million people are living with diabetes in these countries, according to Alimera.