Healthcare Industry News: Advamed
News Release - May 15, 2006
Medtronic Issues Additional Comments on Draft Recommendations by the Heart Rhythm SocietyCompany Looks Forward to Further Dialogue on Key Industry Issues at HRS Conference in Boston
MINNEAPOLIS--(HSMN NewsFeed)--May 15, 2006--Medtronic, Inc. (NYSE:MDT ) today released additional comments regarding recommendations made by the Heart Rhythm Society (HRS) on April 26. These comments will be incorporated into Medtronic's formal response to be submitted during the HRS public comment period.
Steve Mahle, president of Medtronic's Cardiac Rhythm Disease Management, said, "Medtronic is very pleased with the rigor and thoughtfulness that HRS invested in developing its Draft Recommendations Report on Device Performance Policies and Guidelines. Overall, Medtronic is supportive of the majority of HRS' recommendations, and we are pleased to note that Medtronic has been operating well beyond these recommendations in many areas for years."
"Many of HRS' recommendations are already standard practice at Medtronic, and we welcome the new recommendations for industry-wide implementation. We have already begun taking steps to implement these additional approaches at Medtronic and look forward to the continuing dialogue with key stakeholders at the HRS Conference in Boston," added Mahle.
Among the initiatives being adopted by Medtronic:
Advisory Committees on Cardiac Rhythm Management Device Performance
- Medtronic will expand its existing independent Product Performance Panel formerly used to review its Product Performance Report. The Panel will be expanded in size, will meet regularly and will report to the Medical Director of Medtronic's CRDM business. The Panel will review product performance trends and Medtronic's bi-annual Product Performance Report and will perform other device quality related functions as appropriate.
- In addition, Medtronic will expand its existing Quality Advisory Panel of independent physician clinical experts to review, as required, specific product quality issues. This panel will provide Medtronic's CRDM business input regarding clinical manifestations of quality related issues and recommendations on clinical guidance and communications to physicians and patients.
- Medtronic will establish communications vehicles and processes to notify patients of device advisories. Medtronic communications to patients will respect the fundamental role of physicians in regards to patient care and communication.
- Medtronic will establish a Patient Advisory Panel to advise us on communications with patients.
- Medtronic will expand its existing communications materials for physicians to aid them in communicating device therapy benefits and risks to patients.
- Medtronic has adopted recent enhancements to its bi-annual Product Performance Report (PPR), a report which has been consistently published for more than 20 years. This Report remains a comprehensive summary of device performance on Medtronic's pacemakers, implantable cardioverter defibrillators (ICDs) and leads.
- The PPR also includes a System Longevity Study (SLS), a prospective, multi-center study of pacemaker and ICD leads, a critical part of overall system performance. Medtronic has accumulated more than 20 years of data from more than 65,000 leads. Medtronic encourages the adoption of prospective lead analyses into Product Performance Reports from all manufacturers to further improve industry standardization and overall device system analysis.
- Medtronic has been an active member of the Advamed working group to establish and publish industry-wide reliability standards for pacemakers and ICDs.
- Medtronic will also work within Advamed to develop a proposal to publish pooled industry-wide data on ICD and pacemaker performance in 2006 and annually thereafter.
- Medtronic will work to improve systems for encouraging device returns from physicians, hospitals and funeral homes. Furthermore, Medtronic is recommending that an industry-wide awareness and education campaign be undertaken under HRS leadership to improve device returns from these sources.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Quarterly Report on Form 10-Q for the quarter ended January 27, 2006. Actual results may differ materially from anticipated results.
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.
Related News ItemsMedtronic Diabetes announces world's first approval for MiniMed(TM) 780G System with Simplera Sync(TM) disposable, all-in-one sensor
Medtronic receives FDA approval for extravascular defibrillator to treat abnormal heart rhythms, sudden cardiac arrest
Medtronic Diabetes announces CE Mark for new Simplera(TM) CGM with disposable all-in-one design