Hologic receives FDA approval of prone biopsy system

Hologic announced the U.S. Food and Drug Administration (FDA) clearance and commercial launch of the Affirm prone biopsy system, the first dedicated prone biopsy system to offer both 2D and 3D imaging-guided breast biopsies.

With a larger field of view than existing dedicated prone biopsy systems, the new Affirm prone biopsy system allows radiologists to better target lesions found during 3D MAMMOGRAPHY exams, as well as other screening modalities. Furthermore, this new product features a streamlined workflow with increased automation designed to make using the system fast and easy. With the patient lying prone, the biopsy system provides true 360-degree access to lesions using a fully integrated C-Arm. Approach angles can be varied with minimal movement on the patient’s part, as the patient is supported stably throughout the procedure. In addition to these important benefits for clinicians, the system’s design aims to increase patient satisfaction through faster procedure times than Hologic’s market leading MultiCare Platinum system, and comfortable prone positioning that eliminates a direct view of the biopsy needle.

The system is CE marked, and Hologic has begun installing Affirm prone systems at leading imaging sites in Europe. The Affirm prone biopsy system expands Hologic’s breast biopsy portfolio, complementing the Company’s Genius 3D MAMMOGRAPHY exam and Affirm upright biopsy system. This portfolio equips hospitals and imaging centers with the options necessary to provide minimally invasive breast biopsies for their patients.

For additional information on the Affirm prone biopsy system, please visit www.affirmpronebiopsy.com.

Medtronic Launches New Endoscopic Ablation Catheter for Barrett’s Esophagus

Medtronic announced the launch of the new BarrxTM 360 Express radiofrequency ablation (RFA) balloon catheter, which can help in the treatment of Barrett’s esophagus.

“In reducing the progression of dysplastic Barrett’s esophagus to esophageal cancer, the launch of the Barrx 360 Express RFA balloon catheter underscores our commitment to patients,” said Vafa Jamali, president, Early Technologies business in the Medtronic Minimally Invasive Therapies Group. “We believe patients and physicians will benefit from the easier-to-use technology of the Barrx 360 Express catheter, which provides a more precise delivery of RF energy to the targeted area.”

The company is currently launching the Barrx 360 Express RFA balloon catheter in the United States. The catheter is also expected to be available in the EU, Australia and New Zealand in 2016.

More information can be found from Medtronic webiste following this link.

Boston Scientific Announces CE Mark For MRI Labeling of S-ICD Systems

Boston Scientific has received CE Mark approval for the new EMBLEM MRI Subcutaneous Implantable Defibrillator (S-ICD) System, as well as magnetic resonance (MR) conditional labeling for all previously implanted EMBLEM S-ICD Systems.

The EMBLEM S-ICD Systems are treatment options for patients at risk of sudden cardiac arrest (SCA) that leave the heart and vasculature untouched, reducing the risk of complications associated with transvenous implantable cardioverter-defibrillators (TV-ICDs). Initial market release of the new EMBLEM MRI S-ICD System has begun in a small number of European centers with a broad European launch scheduled for early this summer.
In Europe, the EMBLEM MRI S-ICD System joins the growing family of ImageReady MR-conditional devices, all of which are labeled safe for use in a magnetic resonance image setting when conditions of use are met. Patients receiving the EMBLEM MRI S-ICD System as well as patients who previously were implanted with an EMBLEM S-ICD System are now able to undergo full-body MR scans safely in 1.5 Tesla environments when conditions of use are met.

The EMBLEM MRI S-ICD System also includes two new features, SMART Pass technology and Atrial Fibrillation (AF) Monitor™. The SMART Pass technology will help ensure patients receive therapy from the device only when necessary by enhancing the INSIGHT™ Algorithm, which identifies and classifies a heart rhythm for effective arrhythmia treatment. This novel feature will also be added to previously implanted EMBLEM S-ICD Systems through a software update. The AF Monitor feature of the EMBLEM MRI S-ICD System is a new detection tool designed to alert physicians after the identification of AF so they can make more informed treatment decisions for their patients.

In the U.S., the EMBLEM MRI S-ICD System is not available for sale.

Product details can be found from Boston Scientific website by clicking here.

Abbott to Acquire St. Jude Medical

Abbott and St. Jude Medical, Inc. announced on 28 April 2016 a definitive agreement for Abbott to acquire St. Jude Medical, creating a premier medical device leader with top positions in high-growth cardiovascular markets, including atrial fibrillation, structural heart and heart failure as well as a leading position in the high-growth neuromodulation market. Under the agreement, St. Jude Medical shareholders will receive $46.75 in cash and 0.8708 shares of Abbott common stock, representing total consideration of approximately $85 per share. At an Abbott stock price of $43.93(2), this represents a total transaction equity value of $25 billion. The combined company will have an industry-leading pipeline expected to deliver a steady stream of new medical device products across cardiovascular, diabetes, vision and neuromodulation patient care.

St. Jude Medical’s strong positions in heart failure devices, atrial fibrillation and cardiac rhythm management complement Abbott’s leading positions in coronary intervention and transcatheter mitral repair. Together, the company will compete in nearly every area of the cardiovascular market and hold the No. 1 or 2 positions across large and high-growth cardiovascular device markets. This best-in-class combined portfolio will have the depth, breadth and innovation to help patients restore their health, reduce costs for payors and deliver greater value to customers.

A press release and the financial impact of this transaction can be found here by clicking this link.

Vertebral Motion Analysis System Gets CE Mark

Ortho Kinematics‚ Inc. (OKI), a privately held healthcare diagnostics company focused on spine imaging informatics, announced today it has received CE mark approval for its lead product, Vertebral Motion Analysis “VMA”. CE mark approval is required for the commercialization of the VMA in European markets. Prior to securing CE mark approval, the VMA had regulatory clearance from the US Food and Drug Administration (FDA) to commercialize in the United States. With this additional approval, OKI can begin selling the VMA technology in European Countries.

VMA, or Vertebral Motion Analysis, is a diagnostic test for the assessment of spinal motion and radiographic instability. Today’s current test for assessing spinal radiographic instability is ordered over 5 million times per year in the US, largely by spine surgeons, because it provides diagnostic data that is necessary for many patients being considered for potential spine surgery. The VMA has been shown in peer-reviewed studies to increase the sensitivity in detecting radiographic instability with no decrease in specificity relative to today’s current standard test. It has also been shown to be more accurate, repeatable, and result in a lower dose of radiation.

OKI intends to begin commercialization efforts later this year in the United Kingdom, then expand from there. To support commercial efforts, OKI will be working closely with local distribution partners in each country.

A press release can be found from OKI website by following this link.

EOS imaging Received CFDA Approval for the EOS System

EOS imaging announced that the Company has received approval from the China Food and Drug Administration (CFDA) to market the EOS system in China, further expanding the Company’s commercial opportunities in the fast growing Asia Pacific market. The EOS system can now be marketed in 51 countries.

The EOS system is in clinical use in several markets in the Asia Pacific region, including Hong Kong, Singapore, Japan, Australia and Vietnam. In addition, an EOS equipment is installed in a Shanghai hospital where it is being used for clinical studies, creating awareness for the EOS technology in China. The CFDA approval will allow the company to develop commercial activity in this major market, which includes more than 1,200 top grade (3A and 3B) hospitals, within an established distribution partnership.

Experience with the EOS system will be shared with Chinese physicians by several French radiologists and orthopedic surgeons during the upcoming Jishuitan Orthopedics Forum in Beijing, April 22-24, 2016. The Forum is a biennial, multi-disciplinary event focused on orthopedics that attracts more than 3,000 attendees from over 1,200 hospitals. This year, the Forum includes special sessions for Chinese-French exchange across multiple areas of orthopedic treatment, including spine, joint articulation, pediatrics and radiology.

Marie Meynadier, CEO of EOS imaging, said, “CFDA approval is an important milestone that opens a large and growing market opportunity for our Company. It is consistent with our strategy to expand adoption of the EOS system in 3 major regions – North America, Europe-Middle East and Asia-Pacific – to diversify our revenue growth and long-term potential. We are excited to begin commercial activities in China with our local partner, where there is already positive awareness and demand for the EOS system.”

For more information, please visit www.eos-imaging.com.