BrosMed Announces FDA 510(k) Clearance and Launch of Hermes™ NC 0.035 OTW PTA, Achilles™ NC 0.018 OTW PTA and Castor™ NC 0.014 OTW PTA Balloon Dilatation Catheters
December 14, 2016—BrosMed announced FDA 510(k) clearance and launch its Hermes™ NC 0.035 OTW PTA, Achilles™ NC 0.018 OTW PTA and Castor™ NC 0.014 OTW percutaneous transluminal angioplasty (PTA) balloon dilatation catheter for the treatment of patients with peripheral arterial diseases.
Following the semi-compliant PTA family cleared in July 2016 by FDA, named as Atropos™ 0.035, Minerva™ 0.018 and Polux™ 0.014 OTW PTA, the sister series of Non-Compliant PTA, Hermes™ NC 0.035, Achilles™ NC 0.018 and Castor™ NC 0.014 OTW now are available for the USA market.
According to the company, the Hermes™ 0.035 NC OTW, Achilles™ NC 0.018 OTW and Castor™ NC 0.014 OTW are designed to provide outstanding robust balloon and precise diameter control with a comprehensive selection of the balloon sizes on its 0.035-inch, 0.018-inch and 0.014-inch over-the-wire platform respectively. The devices are available in balloon diameters of 2.0 to 10.0mm and lengths of 10 to 150mm and all catheters lengths available of 70cm, 90cm and 150cm. Hermes™ 0.035 NC, Achilles™ NC 0.018 and Castor™ NC 0.014 OTW PTA are constructed with state-of-art engineered balloon technology and the catheters have consistent nominal pressure of 12atm and rated burst pressures of 22atm (Ø2.0-4.0mm), 20atm (Ø5.0-6.0mm) and 18atm (Ø7.0-10.0mm) respectively.
“Again, it is milestone of BrosMed in 2016 and looking forward to the great performance and sales. The Non-Compliant PTA series are able to differentiate ourselves in the PTA market and we have two fists to compete with. The high pressure non-compliant PTA will provide additional advantage compared with semi-compliant one and it will be alternative weapons to the physicians.” said by Jos A.W.J de Korte, General Manager of BrosMed Medical B.V., the Netherlands, the marketing and sales center of BrosMed Medical in Europe.
About BrosMed Medical
BrosMed Medical is more than just a company; we are leading the medical device design and manufacturing revolution.
BrosMed Medical develops, manufactures and markets medical devices primarily used by interventional cardiologists, radiologists and vascular surgeons in angioplasty procedures and other minimal invasive devices.
We provide solutions to our customers through innovative design, effective supply chain management, world-class manufacturing, and flexible channels of distribution and through the development or acquisition of innovative technologies.
BrosMed Medical product portfolio consist of, Artimes™ PTCA, Apollo™ PTCA, Atropos™ 0.035 PTA, Minerva™ 0.018 PTA, Polux™ 0.014 PTA, Hermes™ NC 0.035 PTA, Achilles™ NC 0.018 PTA, Castor™ NC 0.014 PTA, Conger™ Hydrophilic coated wire and series of accessories.