Medtronic Announces Purchase of Innovative Gel Technology for Potential Use in Functional Endoscopic Sinus Surgery (FESS)

MINNEAPOLIS--(BUSINESS WIRE)--Medtronic, Inc. (NYSE: MDT) today announced that it has completed the purchase of rights to a chitosan-dextran gel technology from Adelaide Research & Innovation Pty Ltd. (the commercial development company of the University of Adelaide) in Australia, Robinson Squidgel Ltd., and Otago Innovation Ltd. (a University of Otago company) in New Zealand. Medtronic is acquiring this technology for potential use in developing future products for functional endoscopic sinus surgery (FESS).
“The chitosan-dextran gel technology would enhance Medtronic’s ability to offer innovative, therapeutic products for sinus surgeons to use in postoperative patient care”
More than 525,000 FESS procedures are performed annually in the US.1 The most common complications are bleeding and adhesions,2,3 which are scars that can form at the surgical site as sinus tissues heal after FESS. These adhesions can block the sinuses, potentially causing disease to recur and requiring additional surgery.
The innovative chitosan-dextran gel has been shown in animal studies to provide hemostasis (control of bleeding) and aid in wound-healing after FESS.2 Additionally, a human trial demonstrated that the chitosan-dextran gel resulted in rapid hemostasis immediately after FESS and fewer postoperative adhesions.3
Chitosan is a polymer produced from the chitin of shellfish and squid. Its powerful hemostatic properties have been extensively studied,2-10 leading to its use in a hemostatic bandage distributed to all deployed US soldiers in Iraq and Afghanistan.11
“The chitosan-dextran gel technology would enhance Medtronic’s ability to offer innovative, therapeutic products for sinus surgeons to use in postoperative patient care,” said Mark Fletcher, president of the ENT division of the Surgical Technologies business of Medtronic. “As a leader in the FESS market, we’re pleased to have the opportunity to expand our FESS product portfolio.”

Salient Surgical goes Dutch

ccccccccccccccccccccSalient Surgical Technologies Inc. is going Dutch, opening an office in Amsterdam to spearhead its international sales and marketing efforts.
The Portsmouth, N.H.-based company said it's had a presence in Europe since 2001, when it began marketing a line of surgical sealers, but wants to expand that footprint with its Aquamantys electrosurgical cautery system.
Citing positive results from clinical trials of the device in joint replacement and spine procedures, Salient Surgical said it's aiming to make the system the global standard of care for reducing bleeding during surgery.
Earlier this month Salient and Medtronic Inc. (NYSE:MDT) slapped Bovie Medical Corp. (NYSE:BVX) with a patent infringement lawsuit over the technology used in the Aquamantys system.
The lawsuit, filed in the U.S. District Court for Delaware, accuses Bovie Medical of violating a trio of patents licensed to Portsmouth, N.H.-based Salient with its SEER fluid-assisted electrosurgical system. It seeks a jury trial, a permanent injunction on further infringement, damages on lost royalties and legal fees.
Salient, founded as TissueLink Medical in 1999, banked $15 million from its seventh funding roundin January. Its backers include Medtronic — which owns a nearly 9 percent stake in the company — TLM Investors, QuestMark Advisors and the RiverVest Venture Fund.

FDA Issues St. Jude Warning Letter Over Epicor Surgical Ablation Device

A Warning Letter from the U.S. Food & Drug Administration (FDA) to St. Jude Medical Inc. has been posted on the agency’s web site. The letter alleges that St. Jude promoted the Epicor surgical ablation device to treat atrial fibrillation, a use that has not been approved by the agency.

Surgical ablation devices like the Epicor system are approved for “ablation,” or the burning of tissue, to seal a wound to stop bleeding. While doctors are permitted to use medical devices in any way they see fit, manufacturers are legally barred from marketing or promoting such uses. St. Jude has received the go-ahead from the FDA to investigate the Epicor system’s use in treating atrial fibrillation, but not approval to market it for this use.

In a Warning Letter dated April 23, the FDA cited marketing statements such as one on the St. Jude’s website last year that the Epicor system is “designed to safely, effectively and reproducibly create a classic box lesion in a single step.” According to The Wall Street Journal, the statement referred to a pattern of burns imprinted on the heart during atrial fibrillation surgery. The letter said statements like that violated the Federal Food, Drug and Cosmetic Act.

The letter also said the FDA found similar problems with marketing brochures and materials aimed at physicians.

Recently, St. Jude acknowledged an investigation by the U.S. Department of Justice into similar false marketing claims involving Epicor. In its most recent quarterly report, the firm stated that it had received a letter from the Department in October 2008.

In March, we reported that Medtronic Inc. and Boston Scientific Inc. had confirmed that the Department of Justice was investigating their marketing of the devices. Another firm, AtriCure, agreed to pay $3.8 million to resolve allegations it marketed its surgical ablation devices for the unapproved purpose of treating atrial fibrillation.

It is estimated the about 80 percent of atrial fibrillation patients are effectively treated with drugs. Unfortunately, there are few studies available that compare the safety of ablation to other types of atrial fibrillation treatments. Since 2008, there have been at least five U.S. patient deaths reported to an FDA data base in procedures using AtriCure devices and one involving a Medtronic device.

Vascular Closure - Hemostasis of the femoral artery

Every year, millions of people worldwide undergo a femoral artery catheterization. The early discharge of these patients undergoing elective diagnostic and interventional procedures, such as angiography, percutaneous transluminal coronary angioplasty (PTCA), stenting, atherectomy, and catheter ablation, hinges on the lack of bleeding complications at the access site after the procedure sheath is removed from the femoral artery. The size of the access route, coupled with routine administration of anticoagulants, creates a strong need to stop bleeding at the puncture site as quickly as possible. However, hemostasis must be achieved without producing clotting in the vessels just treated in order to prevent a potentially fatal myocardial infarction or thrombosis. Simple compression – the use of hand pressure, clamps, and/or sandbags – is currently the standard of care for managing femoral vascular access sites following interventional cases. Under this conventional technique, anticoagulation therapy is discontinued for up to four hours prior to vascular closure in order to permit the patient’s clotting capability to return to a normal state.Throughout this period, the introducer sheath remains in place and the patient must remain immobilized to prevent bleeding. Upon sheath removal, direct compression is applied to prevent bleeding and formation of hematomas. While the patient lies flat, a nurse or technician holds direct manual pressure on the site for 20 to 60 minutes until thrombus forms to seal the access site. This monotonous and tiresome task often relies on trained hospital personnel to administer. Use of sandbags and other adjunctive mechanical compression devices like C-clamps may reduce the need for the nurse or other skilled individual to continuously hold initial manual pressure.There is the possibility for these compression devices to slip, necessitating close monitoring of the patient during this critical time to ensure correct compression of the access site. Additionally, these devices have failed to show measurable advantages over hand pressure and may increase patient discomfort. Once hemostasis has been achieved, the patient’s leg must remain motionless for a minimum of six and up to 24 hours (depending on the amount of anticoagulation drug therapy used and the particular procedure) in order to avoid dislodging of the clot, which can lead to internal or external bleeding.

Vascular Closure Products

Morris Innovative - FISH

St.Jude - Angioseal

Medtronic Inc. - EVS vascular stapling system, Clo-Sur PAD

Covidien - VascuSeal

Abbott - Closure S, Perclose A-T, Perclose ProGlide, Prostar, StarClose, Chitoseal

AccessClosure - Mynx

Cardiva - Boomerang

Medafor - MPatch

Sutura - SuperStitch

Vascular Solutions - Duett, Duett Pro, D-Stat

Radi Medical - FemoStop, RadiStop