Boston Scientific hails results from CRT defibrillator study | Research roundup

Cardiac resynchronization therapy defibrillators may be more effective on women than men, according to research sponsored by Boston Scientific Corp. (NYSE:BSX).

An article on the findings published in the Journal of the American College of Cardiology Foundation reported that women with the CRT-D devices experienced a 70 percent reduction in heart failure events compared to a 35 percent reduction for men.

The the data was gathered in an ongoing clinical trial titled "Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy" (abbreviated to MADIT-CRT), that was designed to determine if combined implantable cardiac defibrillator (ICD) and CRT-D devices will reduce the risk of mortality and heart failure.

The published results of the study, "will help draw attention to the benefits of CRT-D treatment for women, and therefore help reduce treatment disparities between women and men," Boston Scientific CRM chief medical officer Dr. Kenneth Stein said in prepared remarks. "CRT-D therapy has historically been underutilized in women compared to men with the same severity of heart disease."

Here’s a roundup of recent clinical trial and scientific study news:

• Concentric Medical announces first patients enrolled in TREVO 2 clinical trial
  Concentric Medical Inc. announced that the first patients were enrolled in TREVO 2 (Thrombectomy REvascularization of large Vessel Occlusions) at Oregon Health & Science University in Portland, Oregon and at Capital Health in Trenton, New Jersey. Oregon Health & Science enrolled the first patient in TREVO 2 and Capital Health was first to use the Trevo device. TREVO 2 is a pivotal clinical trial investigating the safety and efficacy of Concentric’s Trevo Retriever for removing clot from ischemic stroke patients. The Trevo Retriever is the first device utilizing Stentriever technology, a novel method for retrieving clot from the neurovasculature.
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• Protein may be key to new treatment in a childhood cancer
  After analyzing hundreds of proteins produced by the DNA of tumor cells, researchers have identified one protein that may be central to a new treatment for the often-fatal childhood cancer neuroblastoma. Oncologists hope to translate the finding into pediatric clinical trials of a drug that blocks the protein’s activity. “Our study implicates this protein as a promising treatment target for high-risk neuroblastoma,” said pediatric oncologist Kristina A. Cole, M.D., Ph.D., of the Cancer Center at The Children’s Hospital of Philadelphia. “The fact that drugs acting on this protein are already being studied in clinical trials for adult cancers may hasten the process of testing this treatment strategy in children.” Cole is the lead author of a study published online Feb. 2 in the Proceedings of the National Academy of Sciences.
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• MedShape Solutions Inc. Announces Breakthrough in ACL Reconstruction
  MedShape Solutions Inc., a developer of shape memory orthopedic devices, announced the introduction and first human clinical use of ExoShape CL, a two-part PEEK Altera interference fixation device that simplifies and improves soft tissue graft fixation during anterior cruciate ligament (ACL) reconstructive surgery. After receiving 510(k) clearance from the U.S. Food and Drug Administration, the product was used successfully in a knee ligament reconstruction procedure performed by Champ L. Baker, Jr., M.D., at the Jack Hughston Memorial Hospital in Phenix City, Alabama. “I was impressed with the performance of the ExoShape device,” commented Dr. Baker. “I believe that many surgeons will recognize the significant benefits of the ExoShape device and will adopt it for their soft tissue fixation procedures.” MedShape intends to initiate a full market release of the product in June 2011.
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• One-year European Registry data released for popliteal stenting with IDEV Technologies’ SUPERA
  Data from the Leipzig Registry tracking the results of patients treated with the IDEV Technologies SUPERA stent for peripheral arterial disease (PAD) of the popliteal artery were reported during the recent 2011 Leipzig Interventional Course (LINC). The SUPERA stent is CE marked for biliary and peripheral vascular use in Europe. In the United States the SUPERA stent is the subject of an ongoing FDA-approved IDE trial called SUPERB (Comparison of the SUPERA PERipheral System to a Performance Goal Derived from Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery) for treatment of PAD of the superficial femoral artery (SFA).
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• Researchers develop outline that may help weigh benefits of new imaging technologies
  A new article in the February issue of the Journal of the American College of Radiology provides a roadmap for imaging manufacturers to navigate the unique and increasingly complex U.S. regulatory and reimbursement environment. “Evidence Requirements for Innovative Imaging Devices: From Concept to Adoption,” identifies and addresses the five phases of an imaging procedure’s lifecycle and the distinct clinical evidence needs for each phase. This article is authored by Richard Frank, MD, PhD, Vice President, Global Clinical Strategy and Policy, General Electric, Donald W. Rucker, MD, Chief Medical Office, Siemens Healthcare USA, Michael A. Ferguson, PhD, Global Director, Clinical Outcomes and Translational Research, Philips Healthcare and Terry J. Sweeney, Sr. Vice President, Corporate Quality and Regulatory Affairs, Philips Healthcare.
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