WASHINGTON, May 31 (Reuters Health) - The US Food and Drug Administration
(FDA) has approved a new kind of surgical sealant that can prevent air leaks
following lung surgery in cancer patients.
The sealant, called FocalSeal-L, is "painted" on the lung and then activated
using light. It forms a sealant "via chemical and photochemical polymerization
processes," according to an FDA statement issued Tuesday. Applied to sutured or
stapled areas of the lung, it can prevent air leaks from the lung following
surgery to remove cancerous tumors.
Elimination of such air leaks can allow earlier removal of chest tubes and
may result in a shorter hospital stay following the approximately 190,000 lung
surgeries performed in the US each year, according to Focal, Inc., the
Lexington, Massachusetts-based company that manufactures the sealant.
Studies of the sealant found that 39% of patients treated with the sealant
and standard techniques were air leak-free during the postoperative period
compared with 11% of those treated with standard techniques alone ('controls').
While it voted unanimously on May 8 to recommend FDA approval of
FocalSeal-L, the General and Plastic Surgery Devices Panel of the FDA's Medical
Devices Advisory Committee attached several conditions to its recommendation,
including a number of labeling changes and some patient follow-up. For example,
Focal agreed with the FDA to include in the product's labeling a statement that
the sealant is for single use only, as well as a directive warning physicians to
monitor patients for a potentially higher rate of postoperative infection linked
to FocalSeal-L.
The firm will also perform a 5-year annual follow-up of the original 180
clinical trial patients to monitor any differences in cancer development or
recurrence between the treated and control groups.
Focal's pivotal trial showed that FocalSeal-L was effective in sealing the
air leaks that are common in patients who have had a portion of their lung
removed. Eighty-five percent of patients in the study, conducted at centers
including Massachusetts General Hospital and Johns Hopkins Medical Center, had
had cancer-related lung surgery.
While Focal has set FocalSeal-L's formal launch for July, the firm will
begin immediate sales through its exclusive North American distribution partner,
Genzyme Surgical Partners. Genzyme sells FocalSeal-L in Canada and markets other
Focal products including Seprafilm bio-material and Pleur-Evac chest drains and
fluid management systems.
FocalSeal-L is sold in Europe as AdvaSeal by Johnson & Johnson affiliate
Ethicon, which is Focal's exclusive marketing licensee outside the US.
