International -
Did Boston Scientific Use Counterfeit Plastic in Pelvic Mesh?

Vaginal mesh problems are back in the spotlight this week after a scathing 60 Minutes report claimed the company knowingly bought counterfeit plastic materials from a Chinese supplier to produce the devices. Boston Scientific says the claims are "completely false" and based on outdated and previously disproven allegations.

Companies that sell implantable transvaginal mesh devices have been fighting massive, multi-district litigation for years as thousands of U.S. women have complained of severe complications after surgery. Now, a scathing 60 Minutes report on the issue has Boston Scientific up in arms.

CBS aired the 60 Minutes report Sunday evening, uncovering emails that suggest Marlborough, MA-based Boston Scientific knowingly bought counterfeit plastic material from a Chinese supplier to produce the devices and even repackaged the material to hide the fact that it was an imitation product. The show's producers said Boston Scientific declined an interview with 60 Minutes, but the company responded to the claims in a statement issued shortly after the segment aired...

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International -
Management de la qualité : l’ISO 9004 relookée

« Petite sœur » de l’ISO 9001, la norme volontaire ISO 9004 vient d’être révisée. Elle donne des lignes directrices pour déployer un management de la qualité en vue d’obtenir des performances durables dans l’organisation. Comme l’ISO 9001 en 2015, la norme volontaire internationale ISO 9004, l’une de ses petites sœurs, vient d’être relookée. Orchestrée par le comité technique TC 176 de l’ISO (Organisation internationale de normalisation), dans lequel AFNOR représentait la France, la révision a débouché sur un texte publié en avril 2018, disponible dans la collection AFNOR ici neuf ans après...

USA -
FDA Clears FlowTriever, First Device to Pull Blood Clots from Lungs

Inari Medical of Irvine, California won the first FDA clearance for a thrombectomy device to be used for treatment of pulmonary embolisms. The FlowTriever went through a clinical study involving 106 patients with acute pulmonary embolism and RV/LV (right ventricular/left ventricular) ratio of at least 0.9 that were treated using the device instead of commonly used clot busters. According to the company, “the mean RV/LV ratio in the study decreased from a baseline of 1.53 to 1.15 at 48 hours postprocedure, a difference of 0.39 (p<0.0001). The study also demonstrated excellent safety at 30...

International -
Real World Data Could Give Edwards Edge in TAVR

TAVR pioneer Edwards Lifesciences has released positive 30-day data of its Sapien 3 valve at EuroPCR. Edwards Lifesciences is continuing to strengthen its position in the transcatheter aortic valve replacement(TAVR) market by revealing real world data for the Sapien 3 valve. The Irvine, CA-based company presented positive 30-data of the device at EuroPCR . The propensity-matched analysis compared real-world data collected from the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry with outcomes of patients enrolled in the...

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