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 […]
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 […]
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. […]
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 […]
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 […]
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 […]
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.