The U.S. Food and Drug Administration permitted marketing of Hemospray, a new device used to help control certain types of bleeding in the gastrointestinal (GI) tract.
“The device provides an additional, non-surgical option for treating upper and lower GI bleeding in certain patients, and may help reduce the risk of death from a GI bleed for many patients,” said Binita Ashar, M.D., director, division of surgical devices, in the FDA’s Center for Devices and Radiological Health.
GI bleeding can occur in the upper GI tract (esophagus, stomach or small intestine) or the lower GI tract (colon and rectum). Causes of GI bleeding include gastric ulcers, artery or vein (arteriovenous) malformations, diverticulosis, cancer or inflammatory bowel disease. Older patients are at a higher risk of death from severe GI bleeding.
The Hemospray device is intended to treat most types of upper or lower GI bleeding. The device is an aerosolized spray that delivers a mineral blend to the bleeding site. The device is applied during an endoscopic procedure and can cover large areas such as large ulcers or tumors. The device is not intended for use in patients with variceal bleeding, which is bleeding that comes from enlarged veins that develop in certain medical conditions like alcoholic liver disease.
The FDA reviewed data from clinical studies consisting of 228 patients with upper and lower GI bleeding, supplemented with real world evidence from medical literature reports including an additional 522 patients. The Hemospray device stopped GI bleeding in 95 percent of patients within five minutes of device usage. Re-bleeding, usually within 72 hours, but up to 30 days following device usage, was observed in 20 percent of these patients. One serious side effect, bowel perforation, was observed in approximately 1 percent of patients. Hemospray is contraindicated in patients who have a gastrointestinal fistula or are at high risk for experiencing a gastrointestinal perforation.
The FDA permitted marketing of the Hemospray device to Wilson-Cook Medical Inc.
Sunday, September 23, 2018
Wednesday, April 25, 2018
Cohera Medical Inc.® Awarded Patent on its Biodegradable Sealant Technology
Cohera Medical, Inc., a leading innovator and developer of absorbable surgical adhesives and sealants, today announced that the U.S. Patent and Trademark Office (USPTO) has issued the Company a notice of allowance on its patent application, titled “SILANE-CONTAINING MOISTURE-CURABLE TISSUE SEALANT”.
The patent relates to a novel 100% synthetic sealant with several potential surgical applications. The sealant covered by the patent, Sylys® Surgical Sealant, is highly elastic, and has good bonding strength to internal tissues. In addition, the sealant is easy to prepare and apply in the operating theatre and is biocompatible for internal human use. The patent covers the unique chemistry of the sealant allowing for variations that allow for multiple products with varying elasticity and bonding properties, thereby enabling the development of products for multiple clinical applications.
“The unique chemistry of this synthetic sealant is a breakthrough discovery in the field of medical sealants,” said Dottie Clower, PhD, Chief Scientific Officer of Cohera Medical and the patent’s primary inventor. “The development of this technology has taken many years to perfect, and this patent is the culmination of a significant research effort by the company.”
“We are excited to add this patent to our growing intellectual property portfolio, which solidifies our leadership position in internal surgical adhesives and sealants," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. “This patent protects the core of our sealant technology as well as the key features of our sealant products that make them commercially and clinically viable.”
Cohera Medical is currently developing Sylys Surgical Sealant intended to be used as an adjunct to standard closure techniques for the reinforcement and protection of anastomotic junctions in colectomy procedures. Sylys is designed to help reduce anastomotic leakage by providing additional support to the anastomosis during the first few days of healing, when the development of leaks is most likely to occur. Sylys may also have similar leak prevention characteristics in pancreatic resections, lung, and brain applications where there is a need for elimination of often catastrophic leaks of fluid or air during or after surgery. The product is currently undergoing clinical trials in the U.S. for the colectomy indication.
The market for Sylys Surgical Sealant is significant, with more than one million procedures per year worldwide representing a multi-billion dollar opportunity. Due to the unmet clinical need, Sylys would represent a breakthrough in this market that will lead to improved patient outcomes as well as reduced patient management costs for healthcare providers.
The patent relates to a novel 100% synthetic sealant with several potential surgical applications. The sealant covered by the patent, Sylys® Surgical Sealant, is highly elastic, and has good bonding strength to internal tissues. In addition, the sealant is easy to prepare and apply in the operating theatre and is biocompatible for internal human use. The patent covers the unique chemistry of the sealant allowing for variations that allow for multiple products with varying elasticity and bonding properties, thereby enabling the development of products for multiple clinical applications.
“The unique chemistry of this synthetic sealant is a breakthrough discovery in the field of medical sealants,” said Dottie Clower, PhD, Chief Scientific Officer of Cohera Medical and the patent’s primary inventor. “The development of this technology has taken many years to perfect, and this patent is the culmination of a significant research effort by the company.”
“We are excited to add this patent to our growing intellectual property portfolio, which solidifies our leadership position in internal surgical adhesives and sealants," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. “This patent protects the core of our sealant technology as well as the key features of our sealant products that make them commercially and clinically viable.”
Cohera Medical is currently developing Sylys Surgical Sealant intended to be used as an adjunct to standard closure techniques for the reinforcement and protection of anastomotic junctions in colectomy procedures. Sylys is designed to help reduce anastomotic leakage by providing additional support to the anastomosis during the first few days of healing, when the development of leaks is most likely to occur. Sylys may also have similar leak prevention characteristics in pancreatic resections, lung, and brain applications where there is a need for elimination of often catastrophic leaks of fluid or air during or after surgery. The product is currently undergoing clinical trials in the U.S. for the colectomy indication.
The market for Sylys Surgical Sealant is significant, with more than one million procedures per year worldwide representing a multi-billion dollar opportunity. Due to the unmet clinical need, Sylys would represent a breakthrough in this market that will lead to improved patient outcomes as well as reduced patient management costs for healthcare providers.
Tuesday, January 9, 2018
Baxter acquires surgical products
Baxter International Inc., a global medical products company, said Monday that it will acquire two hemostat and sealant products from Mallinckrodt.
It will acquire Recothrom Thrombin topical, the first and only stand-alone recombinant thrombin, and Preveleak Surgical Sealant, which is used in vascular reconstruction.
"Uncontrolled intraoperative bleeding can lead to a wide variety of clinical and economic complications for patients and hospitals. As a leading provider of advanced hemostats and sealants, Deerfield-based Baxter is focused on continually identifying solutions to help meet surgeons' varying needs," said Wil Boren, president of Baxter's Advanced Surgery business. "We are excited about the addition of Recothrom to help surgeons address less severe intraoperative bleeding and Preveleak to complement Baxter's existing portfolio of sealants for cardiovascular and other surgical specialties."
Thrombin is a proven blood coagulation agent -- used on its own or in combination with other hemostats -- that has been estimated to be used in more than one million patients per year in the United States to help surgeons address intraoperative bleeding.
Recothrom is a thrombin-based product indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. As the only topical hemostat from recombinant DNA origin approved in the United States and Canada, Recothrom can be used in pediatric and adult patients with or without antibodies to bovine-derived thrombin.
The acquisition also includes Preveleak, a surgical sealant designed to seal suture holes formed during surgical repair of the circulatory system and to reinforce sutured connections between blood vessels. Preveleak augments Baxter's portfolio of complementary hemostats, sealants and tissue products used in cardiovascular and other surgeries, offering surgeons additional clinically differentiated products to address patients' varying needs. Preveleak is approved in the United States and European Union.
Sales of the proposed acquired products totaled approximately $56 million in the twelve months preceding Sept. 29. Upon closing, the deal is expected to be modestly accretive to Baxter's 2018 adjusted earnings and increasingly accretive thereafter. Under the terms of the agreement, Baxter will acquire Recothrom and Preveleak for an upfront payment of approximately $153 million and potential contingent payments in the future.
The transaction is expected to close in the first half of 2018, subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.
It will acquire Recothrom Thrombin topical, the first and only stand-alone recombinant thrombin, and Preveleak Surgical Sealant, which is used in vascular reconstruction.
"Uncontrolled intraoperative bleeding can lead to a wide variety of clinical and economic complications for patients and hospitals. As a leading provider of advanced hemostats and sealants, Deerfield-based Baxter is focused on continually identifying solutions to help meet surgeons' varying needs," said Wil Boren, president of Baxter's Advanced Surgery business. "We are excited about the addition of Recothrom to help surgeons address less severe intraoperative bleeding and Preveleak to complement Baxter's existing portfolio of sealants for cardiovascular and other surgical specialties."
Thrombin is a proven blood coagulation agent -- used on its own or in combination with other hemostats -- that has been estimated to be used in more than one million patients per year in the United States to help surgeons address intraoperative bleeding.
Recothrom is a thrombin-based product indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. As the only topical hemostat from recombinant DNA origin approved in the United States and Canada, Recothrom can be used in pediatric and adult patients with or without antibodies to bovine-derived thrombin.
The acquisition also includes Preveleak, a surgical sealant designed to seal suture holes formed during surgical repair of the circulatory system and to reinforce sutured connections between blood vessels. Preveleak augments Baxter's portfolio of complementary hemostats, sealants and tissue products used in cardiovascular and other surgeries, offering surgeons additional clinically differentiated products to address patients' varying needs. Preveleak is approved in the United States and European Union.
Sales of the proposed acquired products totaled approximately $56 million in the twelve months preceding Sept. 29. Upon closing, the deal is expected to be modestly accretive to Baxter's 2018 adjusted earnings and increasingly accretive thereafter. Under the terms of the agreement, Baxter will acquire Recothrom and Preveleak for an upfront payment of approximately $153 million and potential contingent payments in the future.
The transaction is expected to close in the first half of 2018, subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.
Tuesday, January 2, 2018
Hemostasis Solution Controls Bleeding during Surgery
A novel handheld device delivers a powder based on collagen to help surgeons achieve hemostatic bleeding control during surgical procedures.
The Biom’Up (Saint-Priest, France) HemoBlast Bellows is a sterile delivery device that is preloaded with a dry, sterile powder made of highly purified porcine collagen, glucose, chondroitin sulfate, and thrombin. The hemostatic powder is applied to the source of the bleeding by squeezing the bellows. Once applied, the powdered collagen and glucose components start the coagulation process by absorbing blood, concentrating coagulation factors and platelets, and providing a surface for autologous coagulation to begin.
In addition to collagen, the thrombin component, collected from pooled human plasma (an ancillary blood derivative) is included in the powder to boost the effect of the hemostatic agent. The thrombin facilitates the conversion of fibrinogen to fibrin, which allows the blood to clot. The chondroitin sulfate powder component provides cohesion between the hemostatic wound and the surrounding tissue. Users do not need to thaw, mix, or heat the powder, which is absorbed by the body within four weeks.
“As the first active hemostatic powder, it will support surgeons in their care for their patients with a simple, effective, and holistic solution for the management of bleeding” said Etienne Binant, CEO of Biom’up. “Biom'up has created innovative and clinically proven products that cover many different surgical specialties - orthopedics, spinal, cardiac, general, and maxillo-facial and dental.”
Studies have shown that during general surgical procedures, the HemoBlast Bellows device achieved 93% efficacy for hemostasis within six minutes, with a significantly shorter preparation time. Common adverse events included abnormal bloodwork, anemia, arrhythmia, and pain, none of which were related to the device itself. No unanticipated adverse device effects occurred.
Collagen is the main structural protein of connective tissue, making up 25-35% of the whole-body protein content. It is one of the body’s key natural resources and a component of skin tissue that can benefit all stages of the wound healing process. The importance of re-establishing a functional extracellular matrix (ECM) in chronic wounds has led to a renewed interest in collagen-based wound healing products, which can be applied either in the surgical or clinical setting, serving as a natural wound dressing with properties that artificial wound dressings do not possess.
The Biom’Up (Saint-Priest, France) HemoBlast Bellows is a sterile delivery device that is preloaded with a dry, sterile powder made of highly purified porcine collagen, glucose, chondroitin sulfate, and thrombin. The hemostatic powder is applied to the source of the bleeding by squeezing the bellows. Once applied, the powdered collagen and glucose components start the coagulation process by absorbing blood, concentrating coagulation factors and platelets, and providing a surface for autologous coagulation to begin.
In addition to collagen, the thrombin component, collected from pooled human plasma (an ancillary blood derivative) is included in the powder to boost the effect of the hemostatic agent. The thrombin facilitates the conversion of fibrinogen to fibrin, which allows the blood to clot. The chondroitin sulfate powder component provides cohesion between the hemostatic wound and the surrounding tissue. Users do not need to thaw, mix, or heat the powder, which is absorbed by the body within four weeks.
“As the first active hemostatic powder, it will support surgeons in their care for their patients with a simple, effective, and holistic solution for the management of bleeding” said Etienne Binant, CEO of Biom’up. “Biom'up has created innovative and clinically proven products that cover many different surgical specialties - orthopedics, spinal, cardiac, general, and maxillo-facial and dental.”
Studies have shown that during general surgical procedures, the HemoBlast Bellows device achieved 93% efficacy for hemostasis within six minutes, with a significantly shorter preparation time. Common adverse events included abnormal bloodwork, anemia, arrhythmia, and pain, none of which were related to the device itself. No unanticipated adverse device effects occurred.
Collagen is the main structural protein of connective tissue, making up 25-35% of the whole-body protein content. It is one of the body’s key natural resources and a component of skin tissue that can benefit all stages of the wound healing process. The importance of re-establishing a functional extracellular matrix (ECM) in chronic wounds has led to a renewed interest in collagen-based wound healing products, which can be applied either in the surgical or clinical setting, serving as a natural wound dressing with properties that artificial wound dressings do not possess.
Subscribe to:
Posts (Atom)