Salute

Vasorum Ltd. Receives FDA Approval for Celt ACD® Vascular Closure Device

- Vasorum Ltd. The developer and manufacturer of the novel Celt ACD® vascular closure device has received approval of its PMA application from the US Food and Drug Administration (FDA). Celt ACD®, which previously received CE mark and is sold in Europe, is indicated for arterial puncture closure in both diagnostic and anticoagulated percutaneous interventional cardiology and radiology patients. Celt ACD® offers excellent time to hemostasis in a wide variety of clinical situations. A randomized controlled clinical trial which recruited 207 interventional cardiology procedure patients was carried out in four International Cardiology Centres across US and Europe. The trial's Principal Investigator was Dr. Shing-Chiu Wong, Director of Cardiac Catheterization at the NewYork-Presbyterian/Weill Cornell Medical Center. Dr Wong commented that he "was very pleased with the positive outcome of the clinical trial which shows that Celt ACD® can help in addressing the clear need for quicker and more efficient methods of increasing patient throughput in healthcare facilities."

(Photo: http://photos.prnewswire.com/prnh/20160706/386513 )

There are currently over 8 million catheter procedures performed annually, which support an estimated $1bn femoral artery closure device market. The number of procedures is expected to exceed 10 million by 2020. In addition to interventional cardiology procedures, the market growth is being driven by an increasing number of peripheral vascular, neuro-vascular and other catheter procedures which demand more patient friendly devices and more efficient patient discharge from hospitals. Given its ease of use and wide clinical applicability, Celt ACD® is well positioned to address this broad and growing market opportunity.

"With more than 20,000 patient implants to date in Europe, Celt ACD® has proven itself to be a best in class arterial puncture closure device. Celt ACD® allows immediate closure of multiple re-sticks in calcified vessels and is also very comfortable for patients. The FDA approval is a very significant milestone allowing US market entry by Vasorum," stated James Coleman MD, co-founder and CEO of Vasorum.

About Vasorum

Vasorum Ltd. is an Irish medical device research and development company supported by Enterprise Ireland that has developed Celt ACD®, a single use femoral artery puncture closure device in three sizes for safe and effective closure of 5F, 6F and 7F punctures. Celt ACD® was designed to be more clinically versatile than other devices by allowing physicians to carry out multiple re-stick procedures and addressing a broader range of clinical situations and patient anatomies. Furthermore the device was designed to help achieve more efficient workflow in the cath lab, by achieving rapid and definitive closure and allowing for earlier ambulation of the patient.

Celt ACD® is currently being used in Europe by cardiologists, radiologists, angiologists and endovascular surgeons with excellent clinical feedback. The technology pipeline includes the development of Celt ACD® to close 12-14F punctures. The company anticipates launch of Celt ACD® in the US market place in Q3 2016.

Further information contact:James Coleman MD CEO, Vasorum, Dublin, Ireland Email: jcoleman@vasorum.ieTelephone: +353-1-403-5460 Website: http://www.vasorum.ie

21 luglio 2016 ADNKronos
Tag scienza - salute -

Codici Sconto

68 Coupon e Nuovi Sconti
Codice Sconto Asos

Codice Sconto Asos

Asos Promocode per risparmiare il 20%

Codice Sconto Farfetch

Codice Sconto Farfetch

Codice Sconto Farfetch 15%

Codice Sconto Luisa Via Roma

Codice Sconto Luisa Via Roma

Codice Promozionale Luisa Via Roma -10%

Codice Sconto Yoox

Codice Sconto Yoox

Codice Sconto Yoox newsletter di 30€

Codice Sconto Zalando Prive

Codice Sconto Zalando Prive

Codice Sconto Zalando Privé del 15% extra Primavera

Codice Sconto Footlocker

Codice Sconto Footlocker

Voucher Footlocker del 15% per la Primavera

Ora in Edicola
Scopri il mondo Focus. Ogni mese in edicola potrai scegliere la rivista che più di appassiona. Focus il magazine di divulgazione scientifica più letto in Italia, Focus Storia per conoscere la storia in modo nuovo ed avvincente e Focus Domande & Risposte per chi ama l'intrattenimento curioso e intelligente.

Settant’anni fa agli italiani arrivò un regalo inaspettato: la televisione. Quell’apparecchio – che pochi potevano comprare e quindi si vedeva tutti insieme – portò con sè altri doni: una lingua in comune, l’intrattenimento garantito, le informazioni da tutto il mondo. Una vera rivoluzione culturale e sociale di cui la Rai fu indiscussa protagonista. E ancora: i primi passi della Nato; i gemelli nel mito e nella società; la vita travagliata, e la morte misteriosa, di Andrea Palladio; quando, come e perché è nato il razzismo; la routine di bellezza delle antiche romane.

ABBONATI A 29,90€

I gemelli digitali della Terra serviranno a simularne il futuro indicando gli interventi più adatti per prevenirne i rischi ambientali. E ancora, le due facce dell’aggressività nella storia dell’evoluzione umana; com’è la vita di una persona che soffre di balbuzie; tutti gli strumenti che usiamo per ascoltare le invisibili onde gravitazionali che vengono dall’alba dell’universo; le pillole intelligenti" che dispensano farmaci e monitorano la salute del corpo.

ABBONATI A 31,90€
Follow us