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October 14, 2021

FDA grants breakthrough designation to Varian’s embolisation device

Embozene microspheres has obtained the status due to its potential to treat knee osteoarthritis.

The US Food and Drug Administration (FDA) has granted breakthrough device designation to Siemens Healthineers company Varian’s Embozene microspheres for genicular artery embolisation (GAE) for symptomatic knee osteoarthritis.

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The medical device obtained the status due to its potential to treat knee osteoarthritis patients.

Intended for lowering blood flow to the periarticular tissue of the joints, GAE prevents the inflammatory process.

Embozene is cleared by the FDA for the embolisation of arteriovenous deformities, uterine fibroids, hypervascular tumours and benign prostatic hyperplasia.

Varian Interventional Solutions president Frank Facchini said: “GAE holds great promise in providing clinicians with a new, non-invasive treatment option, which may not only ameliorate pain but reduce the economic burden of this common disease.

“Varian’s investigational programme for GAE exemplifies our commitment to investing in our core technologies to determine their potential to treat the world’s most debilitating diseases.”

The Breakthrough Device Program of the FDA offers patients prompt access to medical devices that can potentially deliver diagnosis or treatment for fatal or irreversibly debilitating diseases or ailments.

A common type of arthritis, osteoarthritis is a ‘wear and tear’ degenerative joint disease that causes an impact on the cartilage and adjacent tissues.

The knee is the joint that is most impacted with osteoarthritis, and knee osteoarthritis is a major cause of disability in adults in the US.

Estimates show that 14 million people in the US have symptomatic knee osteoarthritis, with 50% of them suffering from an advanced form of the disease.

In March, Varian Medical Systems made an investment in Bend It Technologies, an Israel-based company that is developing steerable microcatheters.

Bend It’s microcatheters are used for minimally invasive peripheral vascular procedures.

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Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
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