North Haven is quietly reaping the economic benefits of landing a large piece of a $3.5 billion global market, thanks to healthcare products company Covidien.
The multinational — based in Dublin, Ireland, with U.S.-based operations in Mansfield, Mass. — has released its third product in a special suture line that is manufactured entirely at its North Haven facility.
The wound closure devices make operations easier and quicker for surgeons.
The company also produces a product called the Endo Stitch, an automated suturing device, in North Haven. That product can reduce time in the operating room and associated costs, according to a new study.
Covidien’s 1.5 million-square-foot facility on 60 acres produces 350 device products and 3,000 suture products for Covidien. It employs 2,495 with 1,847 dedicated to manufacturing. These latest products are just a further expansion of the manufacturing capabilities in North Haven.
The V-Loc PBT (polybutester) non-absorbable wound closure device joins the V-Loc 90 (trade name Biosyn) and V-Loc 180 (trade name Maxon) in the barbed suture line. All three products are produced in North Haven.
The idea of producing a barbed suture is not new, yet Covidien has only one competitor in the marketplace, Quill Medical. While the V-Loc is not an option in all cases, Peter Schommer, vice president-global product marketing for Covidien’s Wound Closure division, stressed it does provide additional options for surgeons.
“The idea of a barbed suture goes back to the 1960s, but the [challenge] has been developing [manufacturing quality],” Schommer said. “We think the market potential is significant.”
The V-Loc PBT (trade name Novafil) allows surgeons to securely close incisions without the need to tie knots. It can be used as a permanent option to close both internal and external wounds, Covidien said. The first V-Loc product, the 180, was launched in October 2009. The devices are said to reduce the time needed to close surgical incisions by up to 50 percent, Covidien said, when compared to standard suturing techniques.
Schommer said each device offers a unique option to surgeons. The V-Loc 90 and 180 products absorb moisture and dissolve, with the V-Loc 90 dissolving the quickest, he said. The new V-Loc PBT does not absorb moisture and is considered a permanent suture.
Surgeons will make a determination on which suture to use based on a number of factors — including a patient’s predicted recovery time, Schommer said.
The V-Loc is a modification of regular suture material, Schommer pointed out, with a pattern cut into the barb to allow it to adhere to the wound. “One of the advantages is it spreads the tension much more evenly across the entire length of the suture line,” Schommer pointed out. “When a suture line fails, sometimes it’s the suture that fails, and sometimes it’s the wound that fails … [this] should put less stress around the suture line.”
Schommer added that the V-Loc is a “functional replacement for a stitch. It could replace a lot, but it certainly cannot replace all sutures,” Schommer added.
Schommer said Covidien believes its product is superior in that “all the barbs face in one direction.” With regular suturing, as the suture is pulled tight, a third hand is usually needed to ensure it remains tight to the skin, Schommer said. “With V-Loc, you eliminate the third hand in the procedure, so (a surgeon can close a wound) with his two hands … It’s certainly a convenience feature,” he added.
In addition to the V-Loc products, Covidien also produces the Endo Stitch in North Haven. The Endo Stitch is a 10mm single-use automated suturing device with two jaws, according to the company. A sutured Endo Stitch needle, loaded from a single-use loading unit, is held in one jaw and can be passed to the other jaw by closing the handles and flipping the toggle levers. The suture is typically used in endoscopic surgery for the placement of interrupted or running stitches in soft tissues.
A new study presented at the American Association of Gynecologic Laparoscopists 40th global Congress of Minimally Invasive Gynecology showed that use of the Endo Stitch device can reduce operating room time by approximately 40 minutes on average, when compared to the same procedures performed with robotic assistance. The result is a $1,800 reduction in cost.
“In this tough economic environment, hospitals, payors and patients all feel pressure to reduce costs and increase efficiency in the operating room,” said study co-presenter Stuart Hart, co-director, University of South Florida Center for the Advancement of Minimally Invasive Pelvic Surgery, in a press statement. “Minimally invasive procedures offer the potential to reduce pain and trauma to the body, as well as to enable quicker recovery resulting from smaller and fewer incisions. Despite the proven benefits, however, the vast majority of hysterectomies are still performed with open techniques.”
The study tested the Endo Stitch during total laparoscopic hysterectomies treating benign conditions. A total of 5,731 patients were identified for the study, with 13 percent of the procedures utilizing the Endo Stitch; 50 percent used robotic assistance, and 37 percent used neither. It was conducted from Jan. 1, 2009, through June 30, 2010.
The results also showed that mean operating room time when Endo Stitch was used was about 20 minutes less when compared to a procedure that used neither the Endo Stitch nor a robot, Covidien said.
Laparoscopic suturing is a difficult skill for surgeons when performed manually. Automated devices, such as robots and Covidien’s Endo Stitch, can shorten the time needed to suture internal tissues, the company said.
