A Medical Device Daily
St. Jude Medical (St. Paul, Minnesota) reported receiving regulatory approval from Japan’s Ministry of Health, Labor and Welfare (MHLW), for the Angio-Seal STS Plus vascular closure device.
It also has received reimbursement approval for the device.
Approved for both percutaneous peripheral and cardiac interventional catheterization procedures, the device enables physicians to quickly seal femoral artery punctures made during those procedures.
The company said Angio-Seal STS Plus is designed to provide physicians with an improved method of sealing catheterization sites, “allowing patients increased comfort and offering hospitals improved efficiencies.”
St. Jude said the device offers “a significant advantage” over the Angio-Seal Millennium vascular closure platform, which has been used in Japanese cath labs since 2004. With the addition of a self-tightening suture, the Angio-Seal STS Plus allows vascular closure to be completed entirely in the catheterization lab, saving labor and reducing the length of time required to complete the procedure.
The Angio-Seal STS Plus device includes a small bioresorbable anchor, suture and collagen pad. The anchor is placed in the artery through a small delivery system and secured against the artery’s interior wall. Then the collagen pad, which is positioned on the outside of the artery, is bound together with the suture to form a secure seal. The self-tightening suture enables the physician to finalize the closure procedure immediately.
Unlike many other vascular closure devices, all components of the Angio-Seal STS Plus device are fully absorbed with 60 to 90 days, so no foreign material permanently remains in the body, the company said.
Nearly 10 million catheterizations are performed worldwide each year. Physicians deliver diagnostic tools or interventional therapies — such as balloons, stents and medications — through the catheter to the point of treatment.
The company said the STS Plus device offers “quick, consistent and predictable hemostasis at the puncture site. Its fast, secure closure reduces the risk of complications and can allow patients to resume activities sooner than if managed with manual compression.”
“Japanese approval for the Angio-Seal STS Plus device will further reinforce the strong worldwide market position that the Angio-Seal system holds,” said Paul Bond, president of St. Jude Medical Japan.
St. Jude said that if physicians need to repeat catheterization at a later time, they can re-access the original site, within 1 cm, when the Angio-Seal STS Plus device has been used to close the original site.
Clinical Imaging Center set for Singapore
A new Clinical Imaging Research Center (CIRC) will be set up by the Agency for Science, Technology and Research (A*STAR) and the National University of Singapore (NUS) to undertake clinical research and advanced biomedical imaging in humans using an extensive suite of state-of-the-art imaging tools from Siemens Medical Solutions (Erlangen, Germany).
The center will be one of the few clinical research sites in the world to use the MR-PET medical imaging solution being developed by Siemens. It will combine 3-tesla MRI with positron emission tomography (PET).
The center will start with the 3T MRI system, and the PET system will be introduced later. By conducting both scans simultaneously with the MR-PET, clinical researchers would be able to define and locate diseases accurately while identifying underlying molecular causes.
Lim Chuan Poh, chairman of A*STAR, said, “The introduction of powerful clinical imaging research capabilities into Singapore will be a major boost to advancing clinical and translational research. A*STAR’s joint venture with NUS and our partnership with Siemens will strengthen the connection between bench and bedside.”
He added, “The research, capabilities and infrastructure at the center will accelerate the advancement of science, positively impact patient care and treatment, and create new opportunities for industry to collaborate with the public sector and tertiary institutions.”
The CIRC will be a focus for development and validation of new imaging methods as well as enable the study of novel interventions in humans. The center will focus on key disease areas of particular relevance to Singapore and the health of its population, such as cancer and neurodegenerative disorders.
As part of the partnership, Siemens will set up a research foundation grant of $2.5 million over five years to support collaborative research in translational medicine at the CIRC.
Regulator signs off on Australian deal
Australia’s competition regulator, the Australian Competition and Consumer Commission (ACCC), said it will not oppose the merger of hospitals operator Healthscope Ltd. and pathology, medical centers and pharmacy services group, Symbion Health Ltd.
The ACCC said it had granted its approval after accepting a Healthscope offer to divest a number of pathology businesses in the northeastern and Gippsland regions of the state of Victoria.
Healthscope also said it would divest pathology assets in Albury, New South Wales.
“Healthscope has undertaken to divest the Gippsland pathology business, Benalla pathology business and Albury pathology business that are operated by Symbion and the Wangaratta pathology business operated by Healthscope, as part of the proposed acquisition,” said an ACCC official.
Symbion Health shareholders are scheduled to vote on the proposed merger with Healthscope on Sept. 11.
Healthscope’s proposal involves paying $2.86 billion in cash and scrip for Symbion, and then selling that company’s consumer and pharmacy services divisions to private equity firms Ironbridge Capital and Archer Capital (IAC consortium) for $1.085 billion.
Hong Kong distributor adds MSI hepatitis kits
Medical Services International (MSI; Edmonton, Alberta) said that its distributor in Hong Kong plans to begin retailing the company’s VScan Hepatitis B and C test kits in Hong Kong and surrounding areas. That distributor is currently retailing the HIV 1 & 2 test kits from MSI throughout Hong Kong and surrounding areas.
The company said the number of VScan HIV test kits being sold on a retail level “continues to increase on a quarterly basis.” It said that adding Hepatitis B & C to the existing marketing plan “will significantly increase the distributor’s volume.”