Over-eager docs prompt Abiomed to halt Protect II trial

ABMD logo

Over-ambitious doctors seem to have prompted Abiomed Inc. (NSDQ:ABMD) to close down a clinical trial of its flagship cardiac assist device.

The Danvers, Mass.-based company pulled the plug on the Protect II trial of its Impella 2.5 heart pump “based on a futility determination at the planned interim analysis regarding the primary end-point, which the company views as likely to be due to unanticipated confounding variables related to the use of rotational atherectomy,” according to a press release.

That’s because surgeons, perhaps emboldened by their patients’ being stabilized by the device, sometimes opted to add atherectomies — which uses a high-speed rotating metallic burr to abrade hardened plaque blockages at speeds of up to 200,000 RPM — to the angioplasty procedures the study called for.

“Atherectomy was an unanticipated variable which resulted from the operators’ decision to ‘do more with Impella.’ Our investigators had unblinded knowledge of the treatment arm after randomization,” noted principal study investigator Dr. William O’Neill in prepared remarks. “It is interesting that operators felt that they could do more complex interventions once randomized to Impella and this in and of itself is an important finding.”

In the 305-patient study, 38 percent of the subjects treated with the Impella suffered adverse events, compared with 43 percent of patients treated using an intra-aortic balloon. But only 32 percent of the Impella cohort (which amounted to 88 percent of the entire patient base in the study) suffered an adverse event when that device alone was used, compared with 72 percent of patients treated both with the device and via atherectomy.

“Impella significantly reduced major adverse events as compared to IAB in the majority of patients in Protect II and the Impella arm had 52 percent lower out of hospital major adverse events as well. This study applies to the 26,000 of the 124,000 IABs utilized in the U.S. annually and we are excited at the prospect of converting the majority of the prophylactic IAB PCI patients,” Abiomed chairman, president and CEO Michael Minogue said.

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