St. Jude CEO: Medtronic’s renal denervation miss doesn’t dampen our spirits

St. Jude CEO: Medtronic's miss doesn't dampen our spirits

St. Jude Medical (NYSE:STJ) CEO Daniel Starks remains steadfast in his pursuit of renal denervation in treatment of hypertension, despite the high-profile clinical trial flop suffered just last week by rival medtech titan Medtronic (NYSE:MDT).

St. Jude will continue with its renal denervation initiatives and Starks still sees the technology as a potential winner, he told an audience today at the J.P. Morgan Healthcare conference in San Francisco.

"I think we’re just in the very early stages of figuring out how to best help patients with a renal denervation procedure, but there’s nothing in [Medtronic’s] announcement that dissuades us from continuing to pursue this," Starks said.

Medtronic’s highly anticipated SYMPLICITY HTN-3 clinical trial, the 1st of its kind to analyze renal denervation in a blinded, sham-controlled manner, failed to meet endpoints for efficacy in treating patients with drug-resistant hypertension. The announcement came as a shock to many, including Starks who said that he and his colleagues were still processing the news and waiting for more data.

"This was unexpected for us, to have a negative result from Medtronic’s trial, and it’s too soon for us to know what to make of that," Starks said. "It really raises far more questions than it provided answers."

Read’s in-depth look at renal denervation and bias in hypertension clinical trials.

Medtronic has yet to release the bulk of the data from the trial, so it’s difficult to analyze the possible reasons that renal denervation failed to produce the types of results that many had anticipated based on previous, less-robust studies. Medtronic conducted the trial with its 1st-generation denervation technology, and it’s possible that newer systems may have done a better job, Starks mused.

"It may be that the trial was done with a technology that was too early-stage – that’s speculative on my part, but that’s among the list of questions that we have," he added. "Was the technology effective or was it that the technology was really too hard to use effectively in an expanded environment?"

There are many more questions that Starks would like answered before making a judgment on Medtronic’s trial, he said, but, meanwhile, the news has done little to dampen his enthusiasm for renal denervation and its promise in treating patients with hypertension.

Starks cited years of clinical studies supporting renal denervation, especially in treating patients whose hypertension isn’t well-controlled with drugs.

"The fact that we had and that there have been favorable early clinical results in numerous other experiences is still valid," Starks said. "There is open surgical data dating back several decades that was favorable to the impact of surgical renal denervation to treat hypertension."

St. Jude has suffered some renal denervation setbacks of its own, announcing in December that the company would halt the Enlightn IV clinical trial, just a few months after it began. The study was slated to assess nearly 600 patients, but it was halted over concerns that Medtronic’s Symplicity device would hit the market and hinder enrollment.

RSS From Medical Design & Outsourcing

  • Herrmann Ultrasonics, Inc. announces its 25 Year Anniversary
    In 1990, Thomas Herrmann, the son of Walter Herrmann, who founded Herrmann Ultraschalltechnik GmbH in 1961, established Herrmann Ultrasonics Inc. in the Chicago area. Hermann Ultrasonics, Inc. is proud to recognize a milestone year in observance of their 25th anniversary. Herrmann Ultrasonics has been focused on providing ultrasonic welding technology for various markets such as […]
  • Consumer Health Applications receive the most attention today, but the future is elsewhere
    Wearables for health fall into a wide range of technologies, functions, use cases and over-arching regulatory frameworks that developers and prospective entrants have to understand in order to effectively compete. Using an underlying taxonomy for human health, we establish a health-focused wearables taxonomy around three major categories—applications, use cases, and form factors—the three areas critical […]
  • Paralyzed men move legs with new non-invasive spinal cord stimulation
    Five men with complete motor paralysis were able to voluntarily generate step-like movements thanks to a new strategy that non-invasively delivers electrical stimulation to their spinal cords, according to a new study funded in part by the National Institutes of Health. The strategy, called transcutaneous stimulation, delivers electrical current to the spinal cord by way […]
  • SCHURTER’s new power entry module offers IP 54 protection with V-Lock cord sets
    SCHURTER is pleased to announce, that its power entry module, series 5707, now offers IP 54 protection with V-Lock cord sets at the power input, in addition to IP 65 protection to the equipment. The sealed module is ideal for use in medical equipment exposed to leaks, drips and spills, as well as equipment subject […]
  • GlobTek presents its latest level VI AC/DC adapter and connverter
    T-43086-WWVV-X.X-Q Model is an addition to GlobTek’s Level VI compliant GT-43086 family and represents GlobTek’s 6 Watt wall plug-in series of AC/DC adapters (power supplies and chargers) with International Interchangeable blades. GlobTek’s changeable input blade system with individual field replaceable input plugs, including: North America and Japan NEMA 1-15P, Australian, UK BS 1363, European CEE […]
  • Sanmina’s familiarity with FDA gets skin treatment product to market fast
    The medical market for cosmetic devices is booming. However, quickly launching new products to meet demand is becoming more challenging because device manufactures face increased regulatory scrutiny. To help meet regulatory requirements, aesthetic and other medical-device OEMs are partnering with electronics manufacturing services (EMS) companies that also offer expertise with the FDA filings necessary to […]
  • Fluid connectors and quick disconnects for IVD equipment from CPC
    Colder Products Company (CPC) offers thousands of tubing connectors, quick disconnects and fittings for smart fluid handling in IVD and analytical equipment. Non-spill connectors speed testing throughput by eliminating drips, preventing air inclusion and increasing operator safety. Panel mount connectors can be added to existing equipment or bottle caps to provide secure, leak-free connections. Puncture […]
  • 310 Watt desktop medical power supply meets efficiency level VI requirements
    Power Partners releases a new 310 Watt medical grade desktop power supply from their PEAMD Series of AC and DC adapters. The 310 Watt unit is packed for ideal performance inside a compact case measuring 7.8 x 4 x 2 in. with a weight of only 3 lbs. The PEAMD310 Series is approved to the latest […]
  • Saelig introduces Multiple Instrument System MIS4 universal test system
    Saelig Company has introduced the ABI Electronics’ Multiple Instrument Station MIS4, an all-in-one testing tool that provides all commonly required test instruments in one compact programmable hardware module, mounted in a compact case or installed in a PC-drive bay. Controlled by ABI’s sophisticated SYSTEM 8 Ultimate PC software with a simple yet programmable operator interface, […]
  • AssurX announces document management software update for small to mid-size companies in FDA regulated industries
    AssurX, an enterprise quality management, risk and regulatory compliance solution provider, announces the release of the latest update to their AssurX document management software. The document management solution provides a cost-effective solution for small to medium sized companies faced with streamlined operations and is fully compliant for FDA regulated industries. Ideal solution for small to […]
  • Saelig presents new Amplicon Impact-R 1100F series computer
    Saelig Company announces the Amplicon Impact-R 1100F series, a fanless system powered by the Intel ATOM D2550 processor. Configured with a high performance 2.5 in. MLC Solid State Drive (SSD), the Impact-R 1100F series is a silent controller system. With options for multiple serial communication ports, the Impact-R 1100F can offer up seven DB9 connections […]

Leave a Reply