During surgery, surgeons employ hemostatic strategies, strategies to stop the flow of bleeding, such as using topical agents, tourniquets, or drains alongside pharmaceutical agents to control bleeding. In more severe cases, blood transfusions can also help in managing bleeding.
Bleeding can occur at the incision site or within other tissues in the body. While bleeding can occur during surgery, it can also arise as a potential complication post-surgery.
Surgical bleeding is traditionally caused by surgical procedures themselves, structural defects, hyperfibrinolysis, or some other disruption of the body's hemostasis, such as blood clotting.
Factors that increase the risk of bleeding include a history of spontaneous bruising, requiring blood transfusions in the past, and patient medication.
There are many methods that can be employed by surgeons to stop/control bleeding. For example, bleeding during surgery can be stopped/controlled through hemostatic strategies such as utilizing hemostatic agents or sealants to mechanically stop the bleeding. Additionally, bleeding can be reduced by withdrawing anticoagulants and using pharmaceutical agents.
Progel™ Pleural Air Leak Sealant is the only sealant FDA approved and clinically proven to seal air leaks in both open and minimally invasive thoracic surgery. Progel is designed for both strength and flexibility and works by forming strong bonds with the lung tissue and can expand as needed for respiration and bleeding control.
Tridyne™ Vascular Sealant offers a unique and simple application solution that helps to control bleeding during thoracic aortic surgery. Made from the formulation of polyethylene glycol and human serum albumin, Tridyne™ Vascular Sealant forms a strong, flexible seal on both tissue and grafts, even in anticoagulated patients to control bleeding.
Arista™ AH is a 100% plant-based absorbable hemostatic powder derived from purified plant starch. Arista™ AH is developed with microporous polysaccharide hemospheres, a patented blood clotting technology that helps control bleeding in a matter of minutes.
Avitene™ Microfibrillar Collagen Hemostat is an active absorbable collagen hemostat that serves to accelerate clot formation. Avitene™ MCH effectively enhances platelet aggregation and the release of proteins from the blood to form fibrin, which plays a role in bleeding control and hemostasis.
Ambulatory Surgery Center Solutions
The BD Ambulatory Surgery Center Portfolio of Category-leading products, innovative solutions and dedicated support is designed to help ASCs improve clinical effiency and enhance paitent care.
BD hemostats come in various forms that all help accelarate natural clot formation in many surgical applications. They facilitate use with features such as preloaded applicators and ready-to-use designs.
BD sealants are designed to meet the needs of clicinans in thoracic and aortic surgery
Surgical Solutions & Products
We offer a full portfolio of surgical products
1. Allen, Mark S. et al, “Prospective Randomized Study Evaluating a Biodegradable Polymeric Sealant for Sealing Intraoperative Air Leaks That Occur During Pulmonary Resection” Annals of Thoracic Surgery 2004; 77:1792-1801. Pivotal study. Data on file.
2. Progel™ Pleural Air Leak Sealant Instructions for Use. M-00443. Davol Inc. Data on file.
3. Davol Inc. In Vitro Bench Testing. Data on File. In vitro test results may not correlate to clinical performance.
4. Brunelli et al. Predictors of prolonged air leak after pulmonary lobectomy. Ann Thorac Surg 2004; 77: 1205-1210. Based on the reported incidence of prolonged postoperative air leak.
5. Okereke, I, Murthy, SC, Alster, JM, Blackstone, EH, Rice, TW. Characterization and Importance of Air Leak After Lobectomy. Ann Thorac Surg 2005;79:1167-1173.
6. Estimated based on 4Q 2014 sales data and an estimate of 1.2 mL kits per procedure.
Intended Use / Indications For Use
Progel™ Pleural Air Leak Sealant is a single use device intended for application to visceral pleura after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks incurred during resection of lung parenchyma.
Do not use Progel™ PALS in patients who have a history of an allergic reaction to Human Serum Albumin or other device components.
Do not use Progel™ PALS in patients who may have insufficient renal capacity for clearance of the Progel™ PALS polyethylene glycol load.
Do not apply Progel™ PALS on open or closed defects of main stem or lobar bronchi due to a possible increase in the incidence of broncho-pleural fistulae, including patients undergoing pneumonectomy, any sleeve resection or bronchoplasty.
Do not apply Progel™ PALS on oxidized regenerated cellulose, absorbable gelatin sponges or any other surface other than visceral pleura as adherence and intended outcome may be compromised.
The safety and effectiveness of Progel™ PALS has not been established in patients with the following conditions:
FEV1 ≤ 40% due to small sample size in the clinical study. In the original pivotal study, all 5 Progel™ PALS and 4 Control patients with FEV1 ≤ 40% had post-operative air leak (POAL); whereas in patients with FEV1 > 40%, 59/93 (63.4%) Progel™ PALS. and 45/53 (84.9%) Control patients had POAL. See Section 7.9 Effectiveness: Primary Effectiveness Outcome in the Instructions for Use.
In a pivotal clinical trial there were 3 subjects in the Progel™ PALS group with AEs that were considered by the investigator to be possibly or probably related to the device. The AEs reported were: chest pain, constipation, gastroesophageal reflux, nausea, cough, dyspnea, pneumothorax, and subcutaneous emphysema. All were reported as a single occurrence in the Progel™ PALS group. Two of the AEs, dyspnea and chest pain, were reported as “severe” and “serious,” respectively and occurred in the same subject. All others were reported as mild or moderate. In a clinical trial there were reports of renal dysfunction, urinary system disorders and deaths within the study population. None of these have been confirmed to be associated with Progel™ PALS.
In a subsequent minimally invasive clinical trial there were no device related adverse events or unanticipated adverse events. The majority of AEs reported in this study were mild or moderate in severity. The majority of SAEs were pulmonary and expected events as part of a lung resection surgery. Two patients died during the course of the study, one due to cardiac arrest and another due to multi-system organ failure; neither were device related or unanticipated.
The details of these clinical trial adverse events can be reviewed in the IFU supplied with the product an d also available at www.bd.com
Caution: Federal (USA) law restricts this device to sale by or on order of a licensed physician or properly licensed practitioner.