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NAMSR News: Lombard Medical Gets the Go Ahead in Japan for Endovascular Stent Graft System

Lombard Medical (EVAR) receives Japanese regulatory approval for its endovascular stent graft system, moving the company forward in its quest to control a bigger share of the endovascular aneurysm repair market..

PRLog - Aug. 5, 2014 - ARLINGTON, Va. -- The Japanese Ministry of Health, Labor and Welfare approved the Oxfordshire, U.K.-based company's lead product, Aorfix, to treat patients with abdominal aortic aneurysms (AAA). The device is the first and only stent graft approved in Japan to treat AAA in individuals with aortic neck angulations up to 90 degrees, the company said in a statement. Aorfix has already secured regulatory approval to treat patients with neck angles up to 90 degrees in the U.S. and Europe.

Lombard will distribute its stent graft system through Medico's Hirata and will roll out commercial sales of the device after securing reimbursement approval, which the company hopes to receive in September.

"Japan is a substantial EVAR market--both strategically and financially--and the approval of Aorfix is a significant milestone for the Company. We are confident that, through Medico's Hirata's experienced and established sales force, we will be able to realize the full potential of Aorfix in this growing market," CEO Simon Hubbert said in a statement. "We look forward to providing Japanese physicians with our uniquely differentiated stent graft approved to address the significant population of patients with complex anatomies who, until today, had no 'on-label' minimally invasive treatment option."

Regulatory blessings help Lombard cash in on a growing market and keep a leg up on the competition. In Japan, the EVAR sector is estimated at $140 million or 10% of the global market in 2013 and has been climbing at an average rate of 18% over the last 5 years, the company said in a statement. Globally, the market for abdominal aortic aneurysm repair rings in at $1.4 billion. Lombard expects U.S. demand for EVAR devices to grow 7% annually over the next 5 years, it said in an F-1 filing.

The approval also comes at a critical moment for the company, as it continues to build upward momentum after filing an IPO. In April, Lombard revived plans to go public with a $55 million NASDAQ debut. The company first filed confidential IPO documents in January. In its first quarter after going public, the company reported a 104% jump in global sales of its Aorfix stent.

Meanwhile, Lombard faces some stiff competition in the Japanese stent graft market from larger device outfits. In May, Boston Scientific ($BSX) rolled out its next-generation drug-eluting coronary stent system in Japan as a way to kick-start revenue growth. The company touts its Promus Premier stent as a safer, more cost-effective option that can reach more challenging artery disease lesions by using a dual-layer balloon and special catheter.


RMSR® Medical Sales Certification offered by the National Association of Medical Sales Representatives is designed for entry level medical device sales reps. The course covers a wide array of topics pertaining to industry knowledge that candidates need to acquire before applying to medical sales positions.

The course and training helps to develop the industry skills, maximizing the candidates’ potential and goals, as well as making them feel valued and stimulated in their role when communicating with members of the medical community. By an applicant acquiring medical sales training and a RMSR Certification, it puts him/her in a position of strength and qualifies them for medical sales jobs. Medical knowledge is key in this industry and when communicating with doctors, surgeons, and nurses etc.

It is extremely important for representatives to use key terminology pertaining to the medical product he/she will be promoting. The only way to succeed in this industry is to garner actual sales. Doctors and Surgeons will not acknowledge a Sales Rep who is not proficient in essential medical terminology, knowledgeable of medical devices/equipment and the anatomy. For those lacking a solid sales background the RMSR course covers knowledge of medical selling techniques and regulation such as Effective Territory Management, Effective Networking, Medical Sales Ethical & Regulatory Guidelines and more.

The National Association of Medical Sales Representative™ (NAMSR) is the largest professional association in the world for Medical Sales Representatives. Through our numerous members, the NAMSR™ provides accredited training, continuing education, information about the industry, up-to-date news, programs to assist medical sales reps in their work, training programs to assist candidates who want to break into the industry and initiatives to improve communication with the medical sales field.

For more information on the NAMSR or the RMSR certification visit www.medicalsalescareer.com or call 800-313-9198

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