Will JAMA heart stent article start another Wall Street stampede?

JAMA

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

  • Molex delivers ISO 13485-compliant, medical-grade surgical cables from its class 100,000 clean room facility
    Molex, LLC operates a fully ISO 146441-1:1999 Class 8-certified clean room, satisfying strict particulate contamination levels specified by ISO-compliant requirements. Located in Thailand, the facility has less than 100,000 particulates (≥0.5µm) per cubic foot of air and manufactures a variety of ISO 13485-compliant medical cables and surgical cables used in operating theatres, hospitals, laboratories and […]
  • Swept-Source OCT: Patent license agreement between Massachusetts General Hospital and Heidelberg Engineering
    Heidelberg Engineering has entered into a patent license agreement with Massachusetts General Hospital (MGH) in Boston. The agreement grants global and exclusive rights to 77 basic patents and patent applications which relate to swept-source OCT technology and its application in ophthalmology. Spectral domain OCT has become indispensable to eye care professionals worldwide to diagnose and […]
  • MIT’s MultiFab presents a stark challenge to incumbent 3D Printer manufacturers’ hardware, software, and business Models
    MIT’s Computational Fabrication Group recently announced the MultiFab, a low-cost 3D printer that can combine up to 10 different resins in one part and also includes a 3D scanning system to identify and fix errors during production. According to Lux Research, these capabilities are rare in commercial 3D printers today due to the manufacturers’ need […]
  • AVX releases Accu-P MP medical grade film chip capacitors for medical devices
    AVX Corporation, a leading manufacturer of passive components and interconnect solutions, has released a new series of thin film chip capacitors specifically designed to meet the demanding performance specifications for implantable medical devices. Delivering extremely tight capacitive tolerances, exceptionally repeatable performance, and remarkably low ESR and high Q at high frequencies—including VHF, UHF, and RF […]
  • RIVANNA commences manufacturing of its Accuro device
    Rivanna Medical announced that it has begun manufacturing its FDA-cleared Accuro device, a handheld and untethered smart-phone-sized device that is designed to guide spinal anesthesia with automated 3D navigation technology in addition to ultrasound imaging of abdominal, musculoskeletal, cardiac and peripheral vascular anatomies. The product will be launched at the ASA annual meeting in San […]
  • FDA seeks public input on Quality Metrics guidance
    by Oliver Wolf, Senior Product Manager, MasterControl In line with the general shift towards risk-driven approaches in the quality management world, FDA is now taking steps towards applying those same principles to its own auditing schedule. At the end of July, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation […]
  • First ‘Ear Wear’ for Active Adults Debuts with MDHearingAid FIT
    If you’ve burned out your ears with earbuds, headphones or decades of other audio abuse but aren’t ready for your grandmother’s hearing aids, not to worry! The new MDHearingAid FIT gets you back in the game with a tiny, FDA-registered, one-size-fits-most solution that doesn’t block your ear canal like old-fashioned in-the-ear hearing aids. The FIT feels […]
  • CardioGenics enters into manufacturing agreement with Ontario-based Plasticap
    CardioGenics Holdings, developer for the In-Vitro-Diagnostics (“IVD”) testing market, announced that it has entered into a manufacturing agreement with Plasticap of Ontario, Canada, pursuant to which Plasticap will manufacture CardioGenics’ proprietary self-metering cartridges for its QL Care analyzer. The term of the agreement is three years and the purchase price for each cartridge shall be […]
  • MTD Micro Molding releases micro materials menu
    MTD Micro Molding, a long-time leader in micro-injection molding, has released an updated “Materials Menu” of materials that can be successfully micromolded to help guide engineers at medical device companies. Material selection is a crucial step in product manufacturability. The correct material drives tolerance, dimension, strength, usabality, speed-to-market, design, critical features, and cost. Through MTD’s […]
  • MedTech Chat: Elastic technology for drug delivery
    Dr. Zhen Gu and Dr. Yong Zhu from North Carolina State University are both co-senior authors of a research paper describing their recent work. Dr. Gu, Dr. Zhu and other researchers from North Carolina State University and the University of North Carolina at Chapel Hill have developed a drug delivery technology that consists of an […]
  • B. Braun’s OEM Division offers large bore normally closed low-pressure check valves
    Infusion therapy and pain management device manufacturer B. Braun said today it is offering normally closed large-bore low-pressure check valves through its valve-focused contract manufacturing OEM division. The valves, offered by Bethlehem, Pa.-based B. Braun, are designed for the intermittent injection of fluids during medical treatment and open automatically when pressure is applied. The newly […]

Leave a Reply