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Essential Medical Devices

Teleflex picks up Essential Medical and its Manta vascular closure device

October 5, 2018 By Brad Perriello

Teleflex (NYSE:TFX) said yesterday that it acquired Essential Medical and its Manta vascular closure device for an unspecified amount. Manta is designed to close punctures at femoral arterial access sites after catheterization procedures, including transcatheter aortic valve replacements, endovascular treatment of abdominal aortic aneurysms, ventricular assist procedures and balloon aortic valvuloplasties. Exton, Pa.-based Essential won CE Mark approval in the […]

Filed Under: Featured, Mergers & Acquisitions, Vascular, Wall Street Beat Tagged With: Essential Medical Devices, Teleflex

Essential Medical closes $14.9M Series B for vascular closure device

September 14, 2016 By Fink Densford

Essential Medical said today that it closed a $14.9 million Series B round to support the development and commercialization of its vascular closure devices. The round was led by Amzak Health and joined by prior backer Royal DSM venture investment arm DSM Venturing, the Malvern, Pa.-based company said. “We are thrilled that Amzak Health has the […]

Filed Under: Catheters, Vascular Tagged With: Essential Medical Devices

Essential Medical wins FDA IDE nod for vascular sealer

August 1, 2016 By Fink Densford

Essential Medical said today it won an Investigational Device Exemption from the FDA to begin a trial of its X-Seal 6F vascular closure device. The 180-patient pivotal study will run across 10-16 sites in the U.S., Canada and the European Union, Malvern, Penn.-baed Essential Medical said. “The X-Seal device provides a necessary improvement to current closure devices. […]

Filed Under: Regulatory/Compliance, Vascular Tagged With: Essential Medical Devices

Essential Medical wins CE Mark for Manta vascular closure device

July 18, 2016 By Brad Perriello

Essential Medical said today that it won CE Mark approval in the European Union for its Manta vascular closure device. The device is designed to close punctures in less than 1 minute, providing immediate hemostasis, using absorbable biomaterials in an “anchor/plug” sealing technology, according to Essential Medical’s website. “We are thrilled to have approval to sell Manta and have […]

Filed Under: Regulatory/Compliance, Vascular Tagged With: Essential Medical Devices

FDA approves trial for Essential Medical’s Manta vascular closure device

July 8, 2016 By Brad Perriello

Essential Medical said today that it won an investigational device exemption for a clinical trial of its Manta vascular closure device. The Manta device is designed to close punctures in less than 1 minute, providing immediate hemostasis, using absorbable biomaterials in an “anchor/plug” sealing technology, according to Essential Medical’s website. The U.S. pivotal study is designed to assess […]

Filed Under: Clinical Trials, Replacement Heart Valves, Vascular Tagged With: Essential Medical Devices

Essential Medical launches Manta device trial

July 27, 2015 By Fink Densford

Essential Medical said today it launched a clinical study of its Manta large bore vascular closure device. The Manta system is designed to close large bore punctures following procedures like transcatheter aortic valve replacements, abdominal aortic aneurysm repairs and balloon aortic valvuplasty, the Malvern, Penn.-based company said. Essential Medical said the device is designed to […]

Filed Under: Cardiovascular, Clinical Trials, Surgical, Vascular Tagged With: Essential Medical Devices

Australian J&J hip lawsuit attracts hundreds, may top $200M | Legal News

April 25, 2012 By MassDevice staff Leave a Comment

gavel

 Hundreds of Australian patients sign on to a lawsuit alleging injury from J&J’s recalled metal-on-metal hip implants

Filed Under: Legal News, News Well, Patent Infringement, Recalls Tagged With: Biolase, depuysynthes, Essential Medical Devices, Hips, Johnson and Johnson, Legal Roundup, Masimo

Johnson & Johnson hires contractor to handle DePuy ASR hip implant recall | Legal Roundup

August 22, 2011 By MassDevice staff Leave a Comment

DePuy

Johnson & Johnson (NYSE:JNJ) is making the unusual move of hiring an outside firm to manage the recall of its DePuy ASR hip implant, a decision that could limit its financial exposure – and limit patients’ access to replacement devices.

The New Brunswick, N.J.-based medical and consumer products conglomerate tapped Broadspire Services Inc. to handle patient claims associated with the recall. Companies typically handle such things in-house, accepting the judgment of physicians about whether a revision surgery is necessary.

Filed Under: Legal News, News Well, Patent Infringement Tagged With: Broadspire Services, depuysynthes, Essential Medical Devices, Hudson Surgical Design, Johnson and Johnson, Legal Roundup, Masimo, Smith & Nephew

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