NAMSR News: Medtronic CoreValve U.S. Pivotal Trial results reveal positive outcomes for patients

WASHINGTON - Nov. 1, 2013 - PRLog -- Medtronic, Inc.  has announced the highly anticipated results from the CoreValve U.S. Pivotal Trial, the first U.S. data presented on the Medtronic CoreValve® System. The study of the novel self-expanding device, presented at a late-breaking clinical trial session of the Transcatheter Cardiovascular Therapeutics (TCT) 2013 Conference, met its primary endpoint in patients who were considered too ill or frail to have their aortic valves replaced through traditional open-heart surgery, with a rate of death or major stroke at one year of 25.5 percent. This result is highly significant (p<0.0001) as it was 40.7 percent lower in patients treated with the CoreValve System than was expected with standard therapy (a pre-specified performance goal of 43.0 percent).

The rate of stroke - one of the complications most concerning to physicians and patients because it increases mortality and affects quality of life - is among the lowest reported. At one month, the major stroke rate was 2.4 percent, and it remained low over time with a one-year rate of 4.1 percent. In addition, in more than 800 extreme risk patients enrolled in the CoreValve Continued Access Study, CoreValve patients experienced an even lower rate of major stroke (1.8 percent at one month).

"The fact that nearly three-quarters of patients were alive and free of strokes at one year is remarkable, given the complex medical conditions and extreme frailty of this population. Not only do the results meet the CoreValve study's safety and efficacy endpoints for patients at extreme risk for surgery, but the positive clinical outcomes and low complication rates set a high standard for what transcatheter valves can achieve," said Jeffrey J. Popma, M.D., director of Interventional Cardiology at the Beth Israel Deaconess Medical Center, Boston, and co-principal investigator of the Trial who presented the results at TCT.

The study also found significant and sustained functional and quality-of-life improvements, with the heart failure symptoms of most patients (90.0 percent) improving at least one class at one year (as measured by NYHA Class), and quality-of-life scores improving 27.4 points at one year (as measured by the KCCQ 100-point scale, in which a 20-point change is considered highly significant).

Overall hemodynamic (blood flow) performance was strong with mean gradients (resistance) of 8.5 mmHg at one month and 8.8 mmHg at one year, similar to the gold standard surgical valves. Paravalvular leak (PVL) rates were low and improved over time with only 11.5 percent of patients having more than mild PVL at one month, which improved to only 4.1 percent at one year. Notably, more than 80 percent of patients with moderate PVL at one month had a reduction in the severity of PVL by one year, an improvement that has not been reported in other major transcatheter aortic valve replacement (TAVR) trials. Furthermore, CoreValve patients with moderate PVL had no greater mortality risk than patients with less PVL.

Major vascular complication rates were low: 8.3 percent at one month and 8.5 percent at one year. Consistent with previous studies on self-expanding technology, the permanent pacemaker rate was 22.2 percent at one month and, importantly, pacemaker implants were not associated with mortality for these patients.

CANDIDATES WHO WANT TO BREAK INTO MEDICAL SALES:

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