A Medical Device Daily

TriVascular (Santa Rosa, California), reported the first Canadian patients treated with its Ovation abdominal stent graft. The system is designed to expand the patient population suitable for endovascular aortic repair (EVAR) by addressing a wider range of diseased anatomy. Cherrie Abraham, MD, Vascular Surgery, McGill University (Montreal, Quebec) performed the first case in Canada at Montreal Jewish General Hospital (JGH; Montreal, Quebec). The second case, also performed at JGH, was performed by Daniel Obrand, MD, Chief of Vascular Surgery, JGH.

“The Ovation abdominal stent graft performed very well in the two cases completed here,“ said Abraham. “We are pleased to be in a position to offer this technology to patients that would otherwise not have a viable treatment option for their abdominal aortic aneurysms. The significantly reduced profile of the delivery catheter will increase the pool of patients to whom we can offer EVAR. This was our first aneurysm patient that has gone home on the same day as his surgery and may be the start of a new paradigm in vascular surgery: Same day surgery for abdominal aortic aneurysm repair for select patients. I think the low profile grafts give us the confidence to send patients home sooner.“

The device is available in Canada under Health Canada's Special Access Program (SAP), which allows doctors to gain access to medical devices such as Ovation in emergency use cases or when conventional therapies have failed, are unavailable, or are unsuitable to treat a patient.

Ovation has been used to treat more than 500 patients worldwide. The device is approved for use by the FDA under a humanitarian device exemption (HDE). In Europe, Ovation is CE marked and is used to treat a broad range of patients with abdominal aortic aneurysms.

TTA qualifies as Continua test lab

Continua Health Alliance (Beaverton, Oregon), an international not-for-profit organization of healthcare and technology companies dedicated to establishing guidelines for combining and applying existing standards to create interoperable, personal connected health products and services, reported that TTA, a provider of ICT standardization and certification, has been qualified as a new Continua test lab in South Korea. This new lab will allow Continua to certify products in the growing Asian market.

TTA's involvement in Continua Plugfests, Test and Certification work group and the Continua Certified Experts (CCEs) program has helped nurture the Alliance's successful certification program. TTA employs a CCE and several test engineers dedicated to ensuring quality Continua Certified products. TTA also provides current Continua transport (Bluetooth, Zigbee, USB) testing and certification services which can help customers to save time for Continua Certification with one-stop service.

“We are grateful for TTA's contribution and commitment to Continua certification,“ said Michael Kirwan, technical operations manager, Continua Health Alliance. “Our test lab standards are very high and we are confident that TTA will continue to exceed our expectations.“

Continua Health Alliance is an international not-for-profit industry organization dedicated to establishing guidelines for combining and applying existing standards to personal connected health products and services. Continua makes a transition from the personal connected health marketplace to a marketplace of interoperable devices that facilitate better care, empower consumers, improve outcomes and lower overall healthcare costs possible. With more than 240 member companies around the world, Continua is comprised of technology, medical device and healthcare industry leaders as well as service providers dedicated to making personal connected health a reality.

Carestream receives Israeli award

Carestream Health (Rochester, New York) has received the National Quality and Excellence Award from the Israeli government for its outstanding achievements and continuous improvement in the area of computed radiography (CR).

This award – honoring the late Prime Minister Yitzhak Rabin – is the most prestigious award of its kind in Israel, and recognizes Israeli organizations for excellence and a commitment to quality. The competitive application process and evaluation is sponsored by the Prime Minister's Office and managed by the Ministry of Industry & Trade, the National Institute of Standards and the Israeli Society for Quality.

The Israeli National Quality and Excellence Award is based on U.S. Malcolm Baldrige National Quality Award established by the U.S. Congress and is awarded annually by the President of the Unites States. Carestream applied for the Israeli award at the beginning of 2011 and went through a long evaluation process by an independent board of examiners

The National Quality and Excellence Award recognizes the achievements of Carestream's Israeli organization that is responsible for designing and developing the company's line of tabletop CR systems that enable medical professionals to acquire patient X-ray images digitally. Israel has created an environment that has helped nurture many successful healthcare and technology companies, including Carestream's Yokneam team which continues to produce outstanding technology and market-leading medical imaging innovations.

Carestream manufactures its CR systems in multiple locations worldwide and supplies them for use in clinics, imaging centers and specialty markets such as orthopedics, veterinary and dentistry.

Mazor in purchase agreement with NHS Michigan

Mazor Robotics (Caesarea, Israel), a developer of surgical robots and complementary products for spine surgery, reported a purchase agreement with NSH Michigan. The Renaissance system will be installed at NSH Michigan's affiliate, the Lakes Surgery Center (West Bloomfield, Michigan). The Renaissance system was recently launched as the new generation of Mazor Robotics Guidance Systems.

With the Renaissance system already in use at U.S. hospitals specializing in spine surgery, this is the first Renaissance system installed in an ambulatory surgery center. According to National Health Statistic Reports, more than 300,000 people in the U.S. seek surgery annually for relief from chronic back pain resulting from spinal disc diseases, including herniations and protrusions. Common spine procedures such as endoscopic discectomy are typically performed in spine surgery centers while other procedures such as spinal fusion are usually performed in hospitals. With new technology like the Renaissance system, more cases can be performed on an out-patient basis with minimal recovery time. There are about 3,300 ambulatory surgery centers in the U.S.

“This purchase agreement with NSH Michigan, Inc. is strategically important for Mazor Robotics as it significantly expands our market opportunity to include ambulatory surgery centers in the U.S.,“ said Ori Hadomi, CEO of Mazor Robotics. “We are also excited about the clinical opportunity this represents, as many more patients will now have access to such minimally invasive procedures.“

Medidata reports first Chinese CRO partner

Medidata Solutions (New York) reported that one of China's contract research organizations (CRO), Tigermed Consulting (Shanghai), is the first Chinese CRO to become a Medidata Services Partner in the Medidata Partner Program. Tigermed will now offer a full suite of services supporting the Medidata Rave electronic data capture and clinical data management solution.

Tigermed has extensive experience in oncology, endocrinology, CNS, virology and cardiology studies. Tigermed selected Medidata to support the company's move from paper processes to EDC and also leverage the company's broad global footprint to strengthen sponsor and site relationships. Offering Medidata Rave to its sponsor clients will help Tigermed better facilitate and enhance the accuracy of clinical trial data capture at every site, provide faster resolution of trial queries and speed trial execution time.