Medtronic's stent graft system for the endovascular repair of isolated lesions approved by the FDA - 14/11/2012

Medtronic, Inc. announced today that the FDA has approved the company's Valiant® Captivia® stent graft system for the endovascular repair of isolated lesions (excluding dissections) of the descending segment of the thoracic aorta. This expanded indication includes the treatment of transections, commonly known as blunt traumatic aortic injuries.

The second leading cause of traumatic death after head injuries, transection of the thoracic aorta represents a dire medical emergency in which the upper area of the body's main artery tears due to extreme force to the chest, usually the result of motor vehicle accidents, elevated falls or other high-impact deceleration episodes.

The Valiant stent graft, a tubular medical device consisting of a specially woven fabric sewn onto a flexible wire-mesh frame, can now be used in U.S. clinical practice to stabilize bleeding from descending thoracic aortic transections as an alternative to invasive surgery.

Previously approved by the FDA for the endovascular repair of aneurysms and penetrating ulcers of the descending thoracic aorta, the Valiant Captivia stent graft system has been widely available in the United States since May 2012.

The device is implanted in a minimally invasive procedure that uses a catheter inserted into the femoral artery, located in the groin. This technique requires only a small incision to access the aorta as opposed to larger incisions required for open surgery.

Medical Sales Jobs

Implantable Electronic Devices Powered By The Ear Itself - 12/11/2012

Deep in the inner ear of mammals is a natural battery - a chamber filled with ions that produces an electrical potential to drive neural signals. In the journal Nature Biotechnology, a team of researchers from MIT, the Massachusetts Eye and Ear Infirmary (MEEI) and the Harvard-MIT Division of Health Sciences and Technology (HST) demonstrate for the first time that this battery could power implantable electronic medical devices without impairing hearing.

The medical devices could monitor biological activity in the ears of people with hearing or balance impairments, or responses to therapies. Eventually, they might even deliver therapies themselves. 

In experiments, Konstantina Stankovic, an otologic surgeon at MEEI, and HST graduate student Andrew Lysaght implanted electrodes in the biological batteries in guinea pigs' ears. Attached to the electrodes were low-power electronic devices developed by MIT's Microsystems Technology Laboratories (MTL). After the implantation, the guinea pigs responded normally to hearing tests, and the medical devices were able to wirelessly transmit data about the chemical conditions of the ear to an external receiver. 

"In the past, people have thought that the space where the high potential is located is inaccessible for implantable devices, because potentially it's very dangerous if you encroach on it," Stankovic says. "We have known for 60 years that this battery exists and that it's really important for normal hearing, but nobody has attempted to use this battery to power useful electronics." 

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Smith & Nephew introduces pioneering new fixation devices and techniques for hip arthroscopy - 08/11/2012

Smith & Nephew, global medical technology business, announced that it has received FDA clearance to expand the indications within the hip for its innovative HEALICOIL™ PK Suture Anchor and OSTEORAPTOR™ Suture Anchor. Indications for the HEALICOIL PK Suture Anchor have been expanded to include abductor repair while those for the OSTEORAPTOR™ Suture Anchor now include labral reconstruction. Both products and new techniques will be showcased at this week’s ISHA (International Society for Hip Arthroscopy) Annual meeting in Boston.

“Hip arthroscopy is not only one of the newest and most exciting frontiers in sports medicine, it’s an area we’ve proudly helped to pioneer,” says Alain Tranchemontagne, Senior Vice President within Smith & Nephew’s Advanced Surgical Devices Division. “By bringing first-to-market devices such as the HEALICOIL PK Suture Anchor and the OSTEORAPTOR Suture Anchor to these emerging techniques, we further strengthen our position as the innovation leaders in hip arthroscopy.”

HEALICOIL™ PK Suture Anchor

“HEALICOIL PK is a truly unique suture anchor and is ideal for abductor repair,” explains Dr. J.W. Thomas Byrd of Nashville TN. “Besides being easily inserted into both hard and osteoporotic bone, it leaves behind a minimal amount of material. Smith & Nephew has always supported emerging techniques for hip arthroscopy and this is yet another example of why I consider them to be the leaders in this space.”

Often referred to as the “rotator cuff of the hip,” tears of the hip abductor tendon are a common cause of lateral hip pain. In fact, estimates show that nearly 25% of middle-aged women and 10% of middle-aged men will develop a tear of the gluteus medius tendon.1 The HEALICOIL PK Suture Anchor was launched earlier this year for use in shoulder repair. It features a unique open-architecture design that uses less material than traditional, solid-core anchors while still providing significantly more thread engagement and greater pullout strength than its competitors.

Also cleared for use by the FDA for abductor repair are the TWINFIX™ Ultra and FOOTPRINT™ Ultra Suture Anchors; giving Smith & Nephew a full range of anchor constructs, materials, sizes and suture configurations for either double or single row fixation techniques.

OSTEORAPTOR™ Suture Anchor

With the OSTEORAPTOR Suture Anchor, surgeons now have a FDA-cleared device and technique for reconstructing a torn or detached labrum. Labral tears in the hip, often associated with a traumatic injury like dislocation, can be a source of chronic hip pain and may even contribute to the development of osteoarthritis.

In standard labral repair, the labrum, a fibrous cartilage ring that rims the hip socket, is reattached to the bony socket of the joint using small anchors and sutures. In cases when the labrum is too degenerated to be repaired, leading hip surgeon, Dr. Marc J Philippon of the Steadman Philippon Research Institute, has pioneered a procedure to reconstruct the soft tissue using the naturally bioabsorbable OSTEORAPTOR Suture Anchor.

“The OSTEORAPTOR has always been my gold standard for hip labral repairs, and now I trust it to deliver the same reliable fixation when doing a reconstruction procedure,” explains Dr. Philippon.

With its combination small size and reliable and strong fixation, The OSTEORAPTOR Suture Anchor allows surgeons to use multiple anchors in a small joint space for a precise and secure repair. These naturally biocompatible suture anchors are made of hydroxyapapatite, a calcium phosphate similar to the mineral found in bone. Also cleared by the FDA for this procedure are the BIORAPTOR Suture Anchor and BIORAPTOR Knotless Suture Anchor.

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma, Smith & Nephew has almost 11,000 employees and a presence in more than 90 countries. Annual sales in 2011 were nearly $4.3 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).

Medical Sales Jobs

Introduction to Trainee Medical Sales Jobs

Joining a medical devices or pharmaceutical company as a medical sales graduate can be very stressful and at the same time rewarding career. You will be employed by the company to promote their medical devices, consumables, equipment or pharmaceuticals to key decision makers, doctors or pharmacists.

These positions usually require great communication, presentation and negotiation skills, as you will be working with people trying to sell, so a flare for sales is necessary. In most cases the positions are field based, you don’t have a base but your company car is your office, you will be spending a lot of time in hospitals, doctor’s waiting rooms. In return, most medical devices companies are offering company cars, laptop, lunch allowance and other benefits plus bonus, based on your sales.

As a Medical Sales Representative you will be visiting doctors, nurses, midwives and other key decision makers in the healthcare industry to make presentations on the medical devices, consumables, theatre products or equipment development by your medical sales company.
In most cases you will receive an initial training course lasting 6 – 8 weeks, covering training about the products that you will be selling as well as different selling techniques.

Depending on the medical devices company any degree subject is acceptable, however life sciences, medically-related degree, or healthcare industry experience can help you go a long way.

Guided Solutions Ltd

Boston Scientific wins CE mark for bioabsorbable coronary stent

The European Union has granted CE mark certification to Boston Scientific's coronary stent system with bioabsorbable technology, designed to improve post-implant vessel healing.

The Synergy Everolimus-Eluting platinum chromium coronary stent system features a combination of bioabsorbable PLGA polymer and everolimus drug to create an ultra-thin, uniform coating that is applied to the outer surface of the stent.

Boston Scientific interventional cardiology division president Kevin Ballinger said the stent also features the company's proprietary platinum chromium alloy and is designed to allow for thinner struts, increased visibility and a low crossing profile for easier deliverability.

"We believe that the result is a premium workhorse drug-eluting stent that eliminates long-term polymer exposure, promotes optimal healing and provides confident deliverability," Ballinger said.

The approval was based on the data from a prospective, randomised, single-blind EVOLVE six-month study, which compared Synergywith the company's Promus Element stent featuring a durable polymer coating applied to the entire stent (inner and outer) surface. 

The results demonstrated non-inferiority to the Promus stent for the primary angiographic endpoint of in-stent late loss, a proxy for efficacy.

At 12 months the Synergy system also demonstrated a target lesion revascularisation (TLR) rate of 1.1% and a stent thrombosis rate of 0%.

"Drug release and polymer absorption occur in parallel and are complete at about three months after stent implantation."

Monish Medical Centre Monish Heart professor and director and EVOLVE study principal investigator Dr Ian Meredith said with the bioabsorbable stent, drug release and polymer absorption occur in parallel and are complete at about three months after stent implantation.

"This exciting advance may improve long-term safety and efficacy compared to current durable polymer DES and perhaps even reduce the need for prolonged dual antiplatelet therapy," Meredith said.

In addition to the EVOLVE study, the company is planning to enrol 1,684 patients for its EVOLVE II trial, designed to support US Food and Drug Administration and Japanese Ministry of Health, Labor and Welfare approvals for the stent.

Synergy will be available in a full range of sizes in selected centres in Europe and other geographies by early 2013, while a broad commercial launch is planned for early 2014, according to the company.

Guided Solutions Ltd