A Medical Device Daily
AGA Medical Holdings (Plymouth, Minnesota) has received regulatory approvals and licenses in China for its Amplatzer PFO Occluder and Amplatzer Multi-Fenestrated Septal Occluder "Cribriform." The company has also received regulatory approval for its Amplatzer Vascular Plug II in China, and its license is pending. The company plans to make the products available through its distributor Abbott Vascular, a division of Abbott (Abbott Park, Illinois).
"We see considerable opportunities in developing markets, such as China, and we are excited to expand our presence there," said John Barr, president/CEO of AGA. "Today's announcement demonstrates our ability to obtain product approvals in important markets, and we look forward to making Amplatzer products more widely available."
AGA designed the Amplatzer PFO Occluder for closure of patent foramen ovale (PFO) defects using a minimally invasive transcatheter procedure instead of surgery. PFO is the most common structural heart defect. The Amplatzer Multi-Fenestrated Septal Occluder "Cribriform" is designed for use in multiple-hole atrial septal defects, an abnormal opening in the wall between the left and right atria.
The Amplatzer Vascular Plugs are designed to provide optimal embolization of peripheral veins and arteries through single device occlusion, full cross-sectional vessel coverage, controlled and precise deployment. The Amplatzer Vascular Plug II has a unique multi-segmented, multi-layered design which significantly reduces occlusion time for transcatheter embolization procedures.
Edwards reports Japanese Sapien implant
Edwards Lifesciences (Irvine, California) the first successful Japanese implants of a transcatheter aortic heart valve using its Edwards Sapien valve.
The transfemoral and transapical valve implantations were performed by Osaka University last month in preparation for Osaka's Senshin-Iryo application submission to the Japanese Ministry of Health, Labour and Welfare.
"We are continuing the momentum of Edwards' global transcatheter heart valve program with the first human implants in Japan. We look forward to providing this important treatment option to more Japanese patients and continuing to demonstrate very strong patient outcomes with the Edwards Sapien valve," said Michael Mussallem, Edwards' chairman/CEO.
The Edwards Sapien valve was approved for sale in Europe in late 2007. It has been used in the treatment of thousands of high-risk patients in both commercial and clinical trial environments, and evaluated as part of nine rigorous scientific studies now complete or underway. In the U.S., it is being studied as part of the world's only randomized, pivotal clinical trial of a transcatheter aortic valve.
Sectra continues its Middle East expansion
Sectra (Stockholm, Sweden) has signed a distribution agreement with Emitac Healthcare, a medical technology company in the United Arab Emirates (UAE) and Qatar.
The agreement is a continuation of the company's expansion in the Middle East, where a partnership was recently established in Saudi Arabia. Emitac Healthcare represents several internationally recognized manufacturers of a broad range of technologically advanced medical and IT equipment. Through this partnership, Emitac Healthcare will become a distributor of Sectra's medical systems in the UAE and Qatar.
Together, the UAE and Qatar have a population of about six million and the modernization of the healthcare market is progressing rapidly.
"With this agreement, we are well-positioned to take advantage of one of the major hubs in the Middle East," says Brian Selman, VP, International Operations at Sectra. "Emitac has a very well-established and highly respected position in the United Arab Emirates market within both the IT and medical fields," he continues.
"Our healthcare market is expanding, and so is the demand for efficient digital mammography systems and medical IT solutions," says Raghavan Srinivasan, CEO of Emitac Healthcare Group. "Our agreement with Sectra will allow us to provide our customers with internationally well-proven solutions to enhance the efficiency of their operations."
Sectra develops and sells IT-systems and products for radiology, mammography and orthopedic departments. More than 1,000 hospitals worldwide use the system daily, together performing over 50 million radiology examinations annually.