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Home » Clinical trials roundup: Abiomed wins conditional FDA approval for Impella study on heart attack recovery

Clinical trials roundup: Abiomed wins conditional FDA approval for Impella study on heart attack recovery

December 4, 2010 By MassDevice staff

Clinical trials roundup

Here’s a roundup of recent clinical trial news:

  • Abiomed Receives Conditional FDA Approval for Study with Impella 2.5 in Reducing Heart Muscle Damage Following PCI in STEMI Patients
    Abiomed, Inc. (NSDQ:ABMD), a provider of heart support technologies, announced it has received conditional approval from the Food & Drug Administration to begin MINI-AMI, a prospective, randomized, controlled multi-site trial to assess the potential role of the Impella® 2.5 in reducing infarct size in patients with ST-elevation myocardial infarction (STEMI). The primary objective of this study is to evaluate whether the adjunctive use of the Impella 2.5 for 24 hours following primary percutaneous intervention (PCI) for STEMI has the potential to limit the infarction of at-risk myocardium compared to primary PCI with routine post-PCI care.
    Read more
  • Midterm results from a multicenter registry on the treatment of infrainguinal critical limb ischemia using a heparin-bonded ePTFE graft
    Over a 7-year period ending in 2008, 425 patients presenting with critical limb ischemia underwent infrainguinal revascularization using a heparin-bonded ePTFE graft in seven Italian vascular centers. The use of a heparin-bonded ePTFE graft provides good early and midterm results, with low rates of late amputations. Primary and secondary patency made this graft an excellent alternative to autologous saphenous vein when it is absent, unsuitable, or of poor quality.

    Read more

  • Inspire Medical Systems Announces FDA approval for Pivotal Clinical Trial
    Inspire Medical Systems, a developer of neuro-stimulation therapies for the treatment of obstructive sleep apnea (OSA), announced that the company has received approval from the Food and Drug Administration (FDA) to begin its STAR pivotal clinical trial.
    Read more
  • KineMed reports clinical data on novel method for identifying and verifying biomarker candidates in cerebral spinal fluid for Parkinson’s Disease to the Michael J. Fox Foundation
    KineMed Inc. presents data on the new use of cerebrospinal fluid biomarkers of microtubule-mediated neuronal transport for the monitoring of disease progression and the advancement of therapeutic interventions in Parkinson’s disease, a debilitating neurological condition with considerable unmet need for new treatments.
    Read more
  • New study shows DNA test highly accurate in predicting curve progression in scoliosis Patients
    A new study shows the SCOLISCORE™ AIS Prognostic Test, a DNA test to determine the likelihood of curve progression in children with mild adolescent idiopathic scoliosis (AIS), an abnormal curvature of the spine, is 99 percent accurate in predicting which children are least likely to progress to a severe curve (Cobb Angle of 40 degrees or more).
    Read more
  • California Stem Cell Inc. files IND to commence phase I clinical trial in spinal muscular atrophy
    California Stem Cell, Inc. and Families of Spinal Muscular Atrophy (FSMA) announced that CSC has filed an investigational new drug application with the US Food & Drug Administration for approval to commence a Phase I safety study on a jointly-developed stem cell-derived motor neuron transplantation therapy for Spinal Muscular Atrophy Type I.
    Read more
  • Micell Technologies enrolls first patient in DESSOLVE I first-in-human study of MiStent DES
    Micell Technologies, TM Inc. announced it has enrolled at Mercy Hospital in Auckland, New Zealand, the first patient in DESSOLVE I (DES with Sirolimus and a bioabsorbable polymer for the treatment of patients with de novo lEsions in the native coronary arteries), a first-in-human clinical trial of the company’s investigational MiStentTM Drug Eluting Coronary Stent System.
    Read more
  • Advanced Cell Technology files IND with FDA for first clinical trial using embryonic stem cells to treat dry AMD
    Advanced Cell Technology Inc. (OTC:ACTC) announced that it has filed an Investigational New Drug (IND) Application with the US Food & Drug Administration to initiate a Phase I/II multicenter study using human embryonic stem cell (hESC) derived retinal pigment epithelial (RPE) cells to treat patients with Dry Age-Related Macular Degeneration.
    Read more
  • Phase 2 clinical study demonstrates safety and efficacy of Vitala™ continence control device
    Vitala™ a novel, non-invasive continence control device, demonstrated safety and efficacy in providing up to 8 hours of temporary continence to people with an end colostomy, according to results of a study published in the journal Diseases of the Colon & Rectum.
    Read more
  • Acupuncture changes brain’s perception and processing of pain
    Using functional magnetic resonance imaging (fMRI), researchers have captured pictures of the brain while patients experienced a pain stimulus with and without acupuncture to determine acupuncture’s effect on how the brain processes pain. Results of the study, which the researchers say suggest the effectiveness of acupuncture, were presented at the annual meeting of the Radiological Society of North America (RSNA).
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  • AAOS fails to consider new research offering level 1 evidence in favor of vertebroplasty
    Results of a large-scale study, “Vertebroplasty vs. Conservative Treatment in Osteoporotic Vertebral Compression Fractures” (VERTOS II), provides Level 1 evidence that vertebroplasty helps relieve the pain caused by vertebral compression fractures at an acceptable cost. The study also helps define the type of patient for whom the procedure is most suitable and effective.
    Read more
  • Abnormal blood vessel function found in women with broken heart syndrome
    A team of Mayo Clinic researchers has found that patients with broken heart syndrome, also known as apical ballooning syndrome (ABS), have blood vessels that don’t react normally to stress. These results offer clues to the cause of this rare syndrome and may help with efforts to identify patients who are more vulnerable to mental stress so that appropriate therapies can be developed. The study is published online in the Journal of the American College of Cardiology.
    Read more
  • A less invasive method of determining the stage of non-small-cell lung cancer proves effective
    A study published in The Journal of the American Medical Association showed that patients may not need a surgical procedure to for doctors to learn the stage of their lung dancer.
    Read more
  • OrbusNeich’s Genous™ stent shows favorable outcomes for treatment of coronary artery bifurcation lesions compared to bare metal stents
    OrbusNeich’s Genous Stent shows favorable outcomes compared to bare metal stents (BMS) for the treatment of coronary artery bifurcation lesions, according to data published online in the journal Atherosclerosis.
    Read more

Filed Under: Business/Financial News, News Well Tagged With: Abiomed, Gift Bans

In case you missed it

  • Zimmer Biomet narrowly avoids shareholder rebuke on executive pay
  • FDA says Philips ventilator recall produced over 21,000 device reports, 124 deaths
  • Boston Scientific’s Acurate Neo2 valve performs well in studies
  • MicroTransponder reports first commercial implantation of its stroke rehab neurostim system
  • Ambu replaces CEO with new leadership
  • Moderna’s first bivalent COVID-19 vaccine booster candidate shows promise
  • AdvaMed joins Biden’s Joint Supply Chain Resilience Working Group
  • FDA clears Accelus’ Toro-L interbody fusion system
  • Teleflex’s UroLift cleared in China to treat BPH
  • Globus Medical announces first surgeries with Excelsius3D
  • Abbott reports positive data on heart valve therapies
  • OncoRes Medical raises another $12.5M
  • NeuroMetrix’s Quell neuromodulation device wins FDA de novo nod to treat fibromyalgia
  • Inogen appoints Agnes Lee as senior VP of investor relations, strategic planning
  • Google Health hires FDA’s chief digital health officer
  • ApiJect picks up $111M investment from Royalty Pharma, Jefferies
  • Expect more heart and lung failure years after COVID, Abbott’s heart failure CMO says

RSS From Medical Design & Outsourcing

  • Zimmer Biomet narrowly avoids shareholder rebuke on executive pay
    An unusually large share of Zimmer Biomet (NYSE:ZBH) investors voted against the orthopedics company’s pay packages for top executives at the annual shareholder meeting. About 54% of voting shareholders supported the pay packages of the company’s five top-paid executives at the May 13 meeting, according to results filed with the SEC yesterday. In 2021, nearly 93%… […]
  • BD, Mitsubishi Gas Chemical partner on better materials for plastic syringes
    BD (NYSE:BDX) announced that it partnered with Mitsubishi Gas Chemical Company on applying new technology to pre-fillable syringes. MGC develops the Oxycapt technology designed to integrate the best of plastic and glass for plastic syringes. BD and Tokyo-based MGC will work together to apply Oxycapt technology to the next generation of pre-fillable syringes (PFS) for advanced… […]
  • Ambu replaces CEO with new leadership
    Ambu today said it has hired board member Britt Meelby Jensen to replace CEO Juan Jose Gonzalez, effective tomorrow. “Since Juan Jose Gonzalez joined as CEO in 2019, Ambu has made good progress and achieved important milestones on the strategic transformation into the world’s largest single-use endoscopy company,” Ambu Chair Jørgen Jensen said in a… […]
  • AdvaMed joins Biden’s Joint Supply Chain Resilience Working Group
    AdvaMed executive Abby Pratt has joined the executive committee for the Biden administration’s Joint Supply Chain Resilience Working Group, the medtech industry association said today. The working group’s members from government and industry will assist with implementation of the National Strategy for a Resilient Public Health Supply Chain. Pratt oversees supply chain issues as SVP… […]
  • Toray develops new stretchable film for medical devices
    Toray Industries has a new stretchable film based on its proprietary polymer Reactis technology, with potential applications that include robotics and biological and industrial sensors. Tokyo-based Toray said it shipped samples to customers and plans research and development efforts to commercialize the new grade of film. “Recent years have increased the potential for developing stretchable… […]
  • Google Health hires FDA’s chief digital health officer
    Former FDA Chief Digital Health Officer of Global Strategy and Innovation Bakul Patel has started a new job with Google after 13 years with the regulatory agency. Patel became senior director, global digital health strategy and regulatory for Google Health earlier this month, he said on LinkedIn. Patel recounted highlights of his “incredible journey since… […]
  • Expect more heart and lung failure years after COVID, Abbott’s heart failure CMO says
    Two years into the COVID-19 pandemic, we know more than ever about the SARS-CoV-2 virus and how quickly it moves to ravage the human body. What remains to be seen is how the virus — and perhaps more importantly, our immune system’s response to it — will affect the health of people long after infection,… […]
  • FDA moves forward with Voluntary Improvement Program to bolster medical device quality
    Kathryn Burke, Emergo Group The U.S. Food and Drug Administration has issued new draft guidance to establish a full-blown voluntary program for improving quality-related processes in medical device manufacturing following promising results of a pilot program. The FDA guidance stems from a pilot undertaken by the agency along with the Medical Device Innovation Consortium (MDIC) in 2018.… […]
  • How Minnetronix Medical helped Lazurite with its wireless surgical camera
    Minnetronix Medical (St. Paul, Minnesota) has played an important development and manufacturing partner role with Lazurite’s wireless surgical camera system. It’s been nearly two months since Lazurite (formerly Indago) announced FDA 510(k) clearance of its ArthroFree system. ArthroFree combines proprietary low-heat, high-intensity Meridiem light engine technology with advanced camera, battery and wireless transmission technologies and… […]
  • Instron releases TrendTracker data analysis workflow platform
    Instron announced that it released the TrendTracker module in Bluehill Central for accelerating data analysis workflows. Norwood, Massachusetts-based Instron designed TrendTracker with an intuitive interface to improve the data analysis workflow of single or multi-location materials testing laboratories. According to a news release, the platform features quick searching and the ability to display and analyze… […]
  • Henry Schein hires former Medline veteran to drive ‘One Distribution’ push
    Henry Schein (Nasdaq:HSIC) today named Dirk Benson as VP and chief commercial officer of the medical device manufacturer and distributor’s North America Distribution Group (NADG). Melville, New York-based Henry Schein is the world’s largest provider of health care supplies and services for office-based dental and medical practitioners, and NADG is the company’s largest business group. The… […]

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