Medtronic Answers Reader Questions

You asked, Medtronic answered. As part of our story on the future of Medtronic, we gave the company a list of questions from our readers. Brian Henry, the Senior Director, Media Relations got back to us via email with the following.
Q. What is the difference between EnRhythm MRI and Revo MRI?
Medtronic: In order to denote the significant advance in pacing technology, to reflect the design changes in the SureScan Pacing System, and to avoid confusion surrounding previous platform products, the EnRhythm MRI SureScan Pacing System was renamed the “Revo MRI SureScan System” after completion of the clinical trial.
Q. We have heard commentary lately that executive compensation structures at most medical device companies actually discourage the pursuit of internal innovation. Can you explain how MDT’s executive compensation structure encourages internal innovation and risk taking? How does MDT deal with the obvious conflict that the dynamics of a typical 5 yr development cycle impose on executives – who realize that most projects will only have a chance to fail rather than succeed under their tenure? Covidien has adopted a new policy which pays executives only on the sale of products created in the last 3 yrs – does MDT have a similar structure? Do you think there is room for improvement in executive compensation?
Medtronic: Medtronic is committed to pay for performance in executive compensation. We believe we appropriately reward innovation across our company.
Q. Is Medtronic interested in adding surgical robotics to their surgical technologies division?
Medtronic: There are frequent innovations in the surgical technology field and we will continue to evaluate opportunities.
Q. Does Medtronic have any comments on the ongoing changes at the Center for Devices and Radiological Health and what effect these changes may have on the 510(k) process?
Medtronic: Medtronic is committed to working with the FDA to bring innovation to patients as safely and effectively as possible. Our size and scale put us in a good competitive position to address current and possible future changes to the 510(k) process.
Q: We saw that you have an online form to submit ideas to Medtronic, does that work?
Medtronic: (From Dr. Osterle, Medtronic Vice President of Medicine and Technology): Yeah it does. It works better in Europe than in America. We have a really interesting thing which is a medical device accelerator that we jointly venture with a couple venture firms in Lausanne. It is on the campus of EPFL, and it turns out that because there is less venture money in Europe than America, often times people with good ideas just can’t get them developed and they will submit them to us. We actually call it Eureka and MD Start. That works very well over there. We are just getting started over here.
Q. First, congratulations to Medtronic on their impressive results in the RESOLUTE All Comers study that was presented at the EuroPCR meeting last month. How is the FDA approval process coming along?
Q. With consideration to late-stent thrombosis and other issues linked with DESs (drug eluting stents), is Medtronic currently exploring any alternatives to DES? e.g., drug-eluting balloons and bare metal stents, resorbable stent technology, etc.
Medtronic: Based on excellent progress with the RESOLUTE clinical program, we continue to expect FDA approval of our Resolute drug-eluting coronary stent in 2012. Meanwhile, we have completed the international launch of the Integrity bare-metal coronary stent, which takes flexibility, deliverability and conformability of a metal arterial scaffold to a new level with its continuous sinusoid technology. And with the Endeavor DES, we offer what is widely regarded as the safe choice for patients at high thrombotic risk — those, for example, with diabetes or acute MI. Multiple studies are underway — OPTIMIZE, for example, in Brazil — to show whether Endeavor patients can uniquely reduce the duration of their dual-antiplatelet therapy from one year (as the current clinical practice and product labeling indicates) to as little as three months without an increase in stent thrombosis.
Globally, we have approximately 20 percent of the coronary stent market: About one in five coronary stents implanted worldwide are made by Medtronic.
Looking ahead, the drug-eluting version of the Integrity stent currently in our pipeline stands to significantly advance the treatment of coronary artery disease in years to come. We’re also developing the technology for a drug-filled stent, which would obviate the need for a polymer to mediate elution (instead using pores). And with our recent acquisition of Invatec, Medtronic is uniquely positioned to make drug-eluting balloons part of standard clinical practice for both coronary and peripheral applications. At this stage in the development of drug-eluting balloons, it’s worth noting that there are important differences in the design, delivery and performance of competing platforms — and that Medtronic Invatec has a highly viable approach, with the clinical data emerging to prove it.
Q. Is Medtronic happy with the Kyphon aquisition? What were the lessons learned?
Medtronic: We are pleased with the Kyphon acquisition and the innovation which we have brought in-house to our spine business. We continue to focus on educating about balloon kyphoplasty and investing in new research and new products.
Q. Where will growth come from in the coming years for the spinal division?
Medtronic: We expect our spine business to return to market growth by the end of our fiscal year 2011. We’re rejuvenating the product pipeline and accelerating the pace of innovation. We’ve increased our international focus, deepened our account penetration, retained our focus on our customers and we’re raising the bar on evidence in biologics.