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FDA seeks expert advice on risks and benefits of MoM hip systems

The U.S. Food and Drug Administration today announced that it is seeking expert scientific and clinical advice on the risks and benefits of metal-on-metal (MoM) hip systems as well as potential patient and practitioner recommendations on the use of MoM hip systems and the management of patients implanted with such devices. FDA will discuss these issues at a two-day expert advisory panel meeting on June 27-28, 2012.

30 Mar 2012

VasoStitch percutaneous access-and-closure system featured at ACC annual meeting

VasoStitch is developing a percutaneous access-and-closure system for the nonsurgical deployment of large-diameter transcatheter therapeutic devices, such as Transcatheter Aortic Valve Implants (TAVI) and Endovascular Aneurysm Repair (EVAR) devices. The VasoStitch system is designed to reduce procedural complexity and eliminate the need for an "open" surgical procedure.

29 Mar 2012

Sientra closes $65M Series C financing

Sientra, a privately-held medical device company focused on the aesthetic and plastic surgery markets, announced today that it closed on its $65 million Series C financing led by Abingworth and with participation by Clarus Ventures, OrbiMed Advisors and all other insiders.

29 Mar 2012

Many medical implants never tested for safety

A new investigation by Consumer Reports reveals that while tens of millions of American consumers live with medical devices implanted in their bodies, many of these implants have never been tested for safety and manufacturers are often required to do nothing more than file paperwork and pay a user fee before bringing their products to market.

29 Mar 2012

New CMS requirement increases ICD placement costs

The cost to place an implantable cardioverter-defibrillator (ICD) increased by $844 per case after a new requirement from the Centers for Medicare and Medicaid Services (CMS) went into effect in February 2010, according to research presented today at the American College of Cardiology's 61st Annual Scientific Session.

27 Mar 2012

Sientra receives FDA approval for new silicone gel-filled breast implant

Today, the U.S. Food and Drug Administration approved a silicone gel-filled breast implant manufactured by Sientra Inc. to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.

27 Mar 2012

Medtronic pacemaker reduces risk of syncope recurrence

Medtronic, Inc. today announced the results of a double-blind, randomized study, ISSUE-3, which found that patients who suffered from fainting due to neurocardiogenic syncope had fewer fainting occurrences when treated with a Medtronic pacemaker.

From Medtronic 27 Mar 2012

ACS symposium focuses on biomimetics

Combining the secrets that enable water striders to walk on water and give wood its lightness and great strength has yielded an amazing new material so buoyant that, in everyday terms, a boat made from 1 pound of the substance could carry five kitchen refrigerators, about 1,000 pounds.

27 Mar 2012

Switch may release fuel and materials for rapid growth and formation of layers that later become organs

Shortly after a mouse embryo starts to form, some of its stem cells undergo a dramatic metabolic shift to enter the next stage of development, Seattle researchers report today. These stem cells start using and producing energy like cancer cells.

26 Mar 2012

Breast implant materials may deter cancer cells from dwelling and thriving

One in eight women in the United States will develop breast cancer. Of those, many will undergo surgery to remove the tumor and will require some kind of breast reconstruction afterward, often involving implants. Cancer is an elusive target, though, and malignant cells return for as many as one-fifth of women originally diagnosed, according to the American Cancer Society.

26 Mar 2012

Peripheral nerve stimulation may help manage neuropathic pain in injured soldiers

An peripheral nerve stimulation technique may be a valuable new approach for relief of severe neuropathic (nerve-related) pain in injured soldiers, reports an article in the March issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society.

22 Mar 2012

Two SpinalMotion's sub-5mm Kineflex|C cervical total disc replacements receive CE Mark

SpinalMotion, developer of the investigational Kineflex lumbar and Kineflex|C cervical disc implants for treating degenerative disc disease (DDD), today announced that it has received CE Mark for two sub-5mm Kineflex|C cervical total disc replacements to address the widest range of patients by best matching disc height to the existing anatomy.

21 Mar 2012

Benvenue Medical initiates enrollment in Luna Interbody System for Fusion Trial

Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair, announced that it has actively started enrolling patients in the Luna Interbody System for Fusion Trial.

20 Mar 2012

Synthes signs license and development agreement with Kuros

Kuros Biosurgery AG, a biotechnology company focused on the development of novel biomaterials and bioactive-biomaterial combination products for trauma, wound and spinal indications has signed a license and development agreement with Synthes, Inc. a leading global medical device company.

20 Mar 2012

Kanghui fourth quarter total net revenue increases 33.6% to RMB96.6M

China Kanghui Holdings, a leading domestic developer, manufacturer and marketer of orthopedic implants in China, today announced its unaudited financial results for the fourth quarter and full year 2011.

19 Mar 2012

47,000 UK women have faulty PIP breast implants

According to Britain's health ministry an additional 7,000 women were fitted with potentially faulty French-made breast implants, raising the total in the U.K.to about 47,000.

18 Mar 2012

Vejthani Hospital offers Unicompartmental Knee Arthroplasty in Thailand

Vejthani Hospital Bangkok offers Unicompartmental Knee Arthroplasty to get better range of motion at Vejthani TJR center, the top international hospital in Thailand.

15 Mar 2012

‘All-metal’ hips may fail more often study finds as experts call for a ban

Metal-on-metal hips were developed to be more durable than traditional implants, which combine a ceramic or metal ball with a plastic socket. But recent experience suggests they may actually do worse, prompting the recall of one device made by Johnson & Johnson that critics argue should never have been allowed on the market.

14 Mar 2012

Florida Hospital purchases Mazor Robotics' Renaissance system

Mazor Robotics Ltd, the leader in innovative surgical robots and complementary products for spine surgery, announced that Florida Hospital has purchased a Renaissance system.

13 Mar 2012

FDA approves Organogenesis oral soft tissue regeneration product, GINTUIT

Today Organogenesis Inc., a business leader in the regenerative medicine field, announced that the United States Food and Drug Administration (FDA) has approved GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen), a cell-based product that has been shown to predictably generate new and aesthetically appealing oral soft tissue (gum tissue).

12 Mar 2012