Will JAMA heart stent article start another Wall Street stampede?


A footnote in a study published in the Journal of the American Medical Assn. about percutaneous coronary interventions may have a ripple effect on Wall Street.

The study gathered data on more than 500,000 PCIs conducted at more than 1,000 U.S. hospitals between July 2009 and September 2010. The researchers determined the appropriateness of each procedure based on the 2009 coronary revascularization appropriate use criteria, a whitesheet generated and endorsed by medical professional societies in 2009 amid growing debate over proper use of PCIs.

While the study found that nearly 85 percent of all procedures were necessary and appropriate and only about 4 percent could be definitely determined inappropriate, that 4 percent figure could echo among the canyons of Wall Street. A similar JAMA article published in January, on the rate of appropriate cardiac rhythm management device implantations, is partially credited for driving a slump in procedure volumes for CRM devices.

The new study on PCIs considered 500,154 procedures, dividing them into acute indications and elective procedures. Among the acute category, which made up nearly 73 percent of the whole, nearly all cases fell within the guidelines. About 1 percent were designated inappropriate and less than half a percent were considered uncertain.

Within the elective category, about half were labeled appropriate, less than 12 percent were considered inappropriate and 38 percent were uncertain.

Across the entire study, less than 5 percent of stent and angioplasty balloon procedures were found to be inappropriate. The 11.2 percent that couldn’t be pegged as within or without the guidelines, however, could send a ripple effect along The Street among med-tech investors.

Witness a Bloomberg report out today: "Heart Procedure to Clear Arteries May Be Misused 12% of Time, Study Finds." Contrast that with the original JAMA news release for the study: "Most PCIs (such as balloon angioplasty) performed in US for acute indications appear warranted."

A CRM study published in January showed that more than one in five implantable cardioverter-defibrillators were placed outside the medical guidelines. That study and a U.S. Justice Dept. probe raised fears of federal prosecution among cardiologists; the pair also fueled sales slowdowns for large cardiac device makers such as Boston Scientific Corp. (NYSE:BSX) and St. Jude Medical Inc. (NYSE:STJ).

In April, St. Jude’s optimistic CEO Daniel Starks insisted that the JAMA study on CRM device usage had little effect on his company’s CRM sales. By early May, Boston Scientific’s cardiac rhythm management unit reported a significant slowdown for the first quarter, with outgoing CEO Ray Elliott conceding that the study and the DOJ probe may have been contributing factors. The slump shouldn’t last long, Elliott maintained, but still the company took a $697 million write-down during the first quarter to account for it.

By the end of May, Medtronic Inc.’s (NYSE:MDT) sluggish CRM sales made the CRM downturn all but official. MDT’s CRM sales dropped 5 percent during the 12 months ended April 29, to $5.01 billion. The drop was primarily attributed to a 6 percent dive for sales of MDT’s defibrillation systems, which went from $3.16 billion in 2010 to $2.96 billion in 2011.

Could something similar be in store for PCI sales?

If headlines are any indication, the panic may be imminent: "Study Finds Too Many Elective Stent Procedures," Medpage Today reported. "Angioplasty unnecessary in some cases, study finds," wrote CNN.

Shares of Boston Scientific, St. Jude and Medtronic stock were all down by the end of the day today. Boston Scientific closed at $7.14, down 1.24 percent on the day; St. Jude was down 1.73 percent to $47.74 and Medtronic dropped 2.97 percent to $37.96.

RSS From Medical Design & Outsourcing

  • 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 […]
  • Gerresheimer to acquire Centor
    Gerresheimer AG, a partner to the global pharmacy and healthcare industry, will further extend its pharmaceutical packaging business with the acquisition of Centor. Gerresheimer has reached an agreement with Nemera Development S.A. to acquire 100% of the share capital of Centor US Holding. “Centor is the highly profitable market leader for plastic vials and closures in […]
  • Methods Machine Tools presents the new Nakamura-Tome NTRX-300
    Methods Machine Tools, a developer of precision machine tools and automation, has introduced the new Nakamura-Tome NTRX-300, a multitasking turning center featuring complete parts machining in one operation, with a built-in load and unload automation system and advanced operator recognition management software. The NTRX-300 features true opposing twin spindles: an 8 in. A2-6 25 HP or […]
  • MSC Apex Diamond Python and Smart Midsurface speeds modeling to validation
    MSC Software announced a new release of MSC Apex, the company’s award-winning next generation Computer Aided Engineering (CAE) platform. The MSC Apex Diamond Python release introduces: · The fourth release of MSC Apex Modeler is a CAE Specific direct modeling and meshing solution that streamlines CAD clean-up, simplification and meshing workflow. New in this release is […]
  • Quality Metrics: FDA’s plan for a key set of measurements to help ensure manufacturers are producing quality medications
    Editor’s Note: This article is written by Ashley Boam and Mary Malarkey from the “FDA Voice” blog. Boam is an FDA’s acting Director of the Office of Policy for Pharmaceutical Quality, the Office of Pharmaceutical Quality and the Center for Drug Evaluation and Research. Malarkey is an FDA’s Director if the Office of Compliance and Biologics Quality […]

Leave a Reply