Medical Device Daily And MDDs
Surgical-IOC (Saint-Etienne, France), a manufacturer of surgical devices, unveiled three products that build on its two areas of specialization for meshes for hernia repair and gastric rings for obesity surgery.
The company, which reported 2006 sales of €2.8 million ($4 million), also said it has invested €2.6 million ($3.7 million) to expand production capacities with the construction of a new facility at Andrézieux-Bouthéon, also in the upper Loire valley.
The newest product for the company’s parietal division is the Sil Promesh, which combines polypropylene with silicone to create an advanced two-sided prosthesis for hernias and eventrations.
The mesh features different properties on either side so that it can be implanted in intraperitoneal sites. The visceral side is made of a non-adherent silicone membrane that reduces cellular incorporations. The parietal side is made of a non-woven polypropylene film, allowing the development of a fibrous anchoring.
Designed for laparoscopy and laparotomy, a macroperforation of Sil Promesh facilitates immediate drainage of inflamed neighboring tissue both pre- and post-operation, the company said.
A 115-patient clinical study performed by Surgical-IOC with the cooperation of four public and three private hospitals sought to evaluate the efficiency and tolerance of this prosthesis in the treatment of umbilical and incisional hernias in intraperitoneal sites, as well as to evaluate patients’ quality of life and estimate the operation costs.
While there were classical — and rare — complications, the prothesis was not the source of these issues, nor did any recurrence observed call into question the implant, the company said. There was a good evolution in patient comfort and after six months ultrasonographic controls of 42 patients showed no adherence of the implant on the bowels.
The ByPass-Band introduced by Surgical-IOC is designed exclusively for banding a gastric pouch in the laparoscopic procedure called Roux-en-Y bypass, where the stomach is made smaller by creating a small pouch at the top of the stomach using surgical staples or a plastic band.
The ByPass-Band is made of non-adherent and radio-opaque silicone pre-formed to facilitate positioning through a 12 mm trocar. Three closing notches for banding are available, ranging up from 60 mm to a maximum of 75 mm, or about three inches.
The Soft Gastric Band Premium has been introduced to the French market, where Surgical-IOC draws three-fourths of its sales, and features an annular compression chamber by which it is possible, after implantation, to adjust the diameter of the opening by injecting or withdrawing the pressure maintained by a liquid. The maximum inflation is 9 cubic centimeters through a catheter exiting the patient’s body.
Preformed and offered in three sizes from 100 mm to 125 mm, the Premium model is fabricated from the same non-adherent and X-ray opaque silicon material used in its line of soft gastric bands.
Sorin’s Mitroflow valve FDA-approved
The Sorin Group (Milan, Italy) said it has received FDA approval for marketing of its Mitroflow Aortic Pericardial Heart Valve in the U.S.
The company noted that biological valves have become “an increasingly viable option to replace native diseased valves, since they are designed to improve patient quality of life by negating the need for lifelong anticoagulation therapy.”
The Mitroflow Aortic Pericardial Heart Valve will be distributed in the U.S. by American heart valve subsidiary CarboMedics (Austin, Texas). The commercial launch is scheduled for December.
Sorin introduced the Mitroflow Aortic Pericardial Heart Valve in Europe in 1982. It said that in its long years of clinical use, the valve has demonstrated “superior hemodynamic performance and long-term durability in a design recognized by surgeons worldwide as facilitating implant in even the most challenging anatomies.”
“To date, the Mitroflow pericardial bioprosthesis has demonstrated excellent durability at 21 years,” said Charles Yankah, MD, associate professor of surgery at Charité Medical University (Berlin) and consultant cardiothoracic and vascular surgeon at Berlin Herzzentrum.
Joseph Bavaria, MD, professor and vice chief of cardiovascular surgery at the Hospital of the University of Pennsylvania (Philadelphia), said, “Mitroflow will allow U.S. cardiac surgeons to use an innovative and clinically proven biological heart valve leading to excellent hemodynamic performance. Frankly, it [Mitroflow] is one of the easiest aortic heart valves I’ve ever implanted. I especially like the flexible cuff.”