HDH Medical Launches BYFixTM -- COMPAMED Trade Fair


Invibio Ltd.

HDH Medical Launches BYFixTM

HDH BYFix Device
HDH Medical Launches BYFixTM, an Innovative Suture-Less Anastomotic Device to Simplify Open & Laparoscopic Anastomosis of Large Blood Vessels

THORNTON-CLEVELEYS, UK–Surgeons now have an effective alternative to suturing to achieve both open and laparoscopic large-blood vessel anastomosis. HDH Medical’s innovative BYFixTM anastomotic device is composed of an advanced polymer based biomaterial called PEEK-OPTIMA, manufactured by Invibio Biomaterial Solutions. BYFix is used to mechanically connect any standard vascular graft to the blood vessel of a patient within minutes creating leak-proof and reliable anastomosis.

Machined from PEEK-OPTIMA rods, the unique conical design advances existing treatments for aortic and peripheral aneurysms, arterial occlusion and blood vessel trauma. Flexible metal barbs are assembled on the high performance polymer cone attach and affix to the blood vessel wall without future migration. The flexibility of the PEEK-OPTIMA cone and its projecting metal barbs prevents trauma to the vascular wall.

Suturing has long been the standard procedure for vascular graft/blood vessel connection. However, it is also the most technically challenging and time consuming aspect of both open and laparoscopic vascular procedures. Now, instead of sutures, a surgeon can use BYFixTM Anastomotic device and surgical instruments kits to connect all leading commercially available vascular grafts to the patient’s blood vessel wall without leakages or migrations. BYFixTM suture-less devices reduce anastomosis, cross-clamping time, complications and cost, while improving outcomes.

According to HDH Medical CEO, Irina Kavounovski, although BYFixTM is the first HDH device design to incorporate PEEK-OPTIMA, it likely will not be the last.

“During BYFix’ developmental stages we evaluated biomaterials including PEEK-OPTIMA and POMc (Poly Oxy Methylen Copolymer). PEEK-OPTIMA was chosen because of its proven biocompatibility and mechanical properties. However, the expertise around the biomaterial and the technical and regulatory support we received from Invibio were as valuable to our product development efforts as Invibio’s high quality, reliable supply of PEEK-OPTIMA is to our manufacturing efforts, ” she commented.

“Another value-added benefit of working with Invibio is PEEK-OPTIMA’s versatility,” Kavounovski added. “We’re currently CNC turning the PEEK-OPTIMA cones used in the BYFixTM device, but in the future we plan to seamlessly transfer to injection molding.”

HDH Medical has introduced its BYFixTM Device and Toolkit in 2010 and is currently marketing the CE-Marked implant in Europe. Clinical trials and post-marketing studies have successfully demonstrated its safety and efficacy for treatment of Abdominal Aortic Aneurysms (AAA), Aorto-Iliac Aneurysms (AIA), Aortic Occlusions and above the knee arterial occlusions.