Tag: vascular closure
PATCH clinical study of PerQseal vascular closure system reaches 100-patient milestone
Vivasure Medical has enrolled the 100th patient in its PATCH clinical study, a multicentre, single-arm, pivotal study evaluating the safety and efficacy of the...
US FDA grant premarket approval to Manta vascular closure device
Teleflex has received premarket approval (PMA) from the US FDA for the Manta vascular closure device. A press release reports that the device is...
Teleflex acquires Essential Medical
Teleflex Incorporated has announced that it has acquired Essential Medical, a privately-held medical device company that has developed and commercialised the CE Marked Manta...
Terumo enters purchase agreement for XPro large bore vascular closure system
Terumo has entered into a definitive asset purchase agreement with Medeon Biodesign for its XPro large bore vascular closure system. The transaction consists of an...
Manta large bore vascular closure device to be evaluated in 500-patient...
Essential Medical has announced initiation of enrolment in a post-market clinical registry in the regions where Manta is commercially available.
Principal investigator Nicolas Van Mieghem,...
Vasorum launches Celt ACD second generation vascular closure device in the...
Following FDA approval of its PMA supplement, Vasorum has added a 7F Celt ACD vascular closure device to its Celt ACD 6F and Celt...
Medeon Biodesign gets approval for CE mark study for the XPro...
Medeon Biodesign has received approval by the New Zealand Health and Disability Ethics Committees, Ministry of Health to commence the CE clinical trial for...
Essential Medical addressing the growing large bore vascular closure market
Essential Medical has announced the publication of the MANTA CE marking study results in JACC Interventions titled: “Percutaneous plug-based arteriotomy closure device for large-bore...
US trial of Essential Medical’s MANTA device begins
Essential Medical has announced the start of the Manta vascular closure device US pivotal trial.
The first US case was performed on November 28 by...
Terumo signs to acquire St Jude Medical and Abbott’s vascular closure...
Terumo has reached an agreement with Abbott and St Jude Medical to acquire certain products owned by both for a total of US$1.12 billion.
Based...
Essential Medical announces closing on US$14.9 million series B funding
Essential Medical has announced that it has completed a series B financing of US$14.9 million. The round was led by Amzak Health along with...
Essential Medical receives FDA approval for X-Seal 6F vascular closure device...
Essential Medical has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin the US clinical trial of...
Vasorum receives premarket FDA approval for Celt ACD vascular closure device
Vasorum has received approval of its premarket approval application from the US Food and Drug Administration (FDA). Celt ACD, which has received CE mark and...