News

PuraStat reduces delayed bleeding after colorectal submucosal dissection: a new study presented at ESGE Days 2024

3dm-events@puramatrix.com (3-D Matrix) — Fri, 28 Jun 2024 09:30:00 GMT

Delayed bleeding represents an important postoperative complication following endoscopic submucosal dissection (ESD).

Presented by L. Schmutte et al. at the ESGE Days 2024, this new retrospective study compared the delayed bleeding rate within 30 days after ESD with and without PuraStat’s application. In a cohort group of N=225 patients, N=108 (48%) received PuraStat after resection ⁽¹⁾.

Below is shown the notable impact of PuraStat application on delayed bleed rates, compared with the control group:

Resection sites	Delayed Bleed Rates (%)
Resection sites	With PuraStat	Without PuraStat
Colorectum	7.14%	18.2%
Oesophagus	0%	3.2%

No adverse events related to PuraStat occurred.

In conclusion, the study outcomes demonstrated that PuraStat’s application after ESD can significantly reduce the incidence of delayed bleeding, particularly in the colorectum, highlighting its safety and efficacy ⁽²⁾.

Click here to read the full abstract.

PuraShield: the new medical device for ENT has been launched in Spain

3dm-events@puramatrix.com (3-D Matrix) — Fri, 05 Apr 2024 08:30:00 GMT

Operating successfully in the Spanish market with its existing flagship products, PuraStat for gastroenterology and PuraBond for cardiac surgery, 3-D Matrix is thrilled to announce the expansion of its product portfolio with the introduction of PuraShield, a cutting-edge haemostatic agent, specifically designed for use in Ear, Nose, and Throat (ENT) surgical procedures.

PuraShield is licensed as a medical device for achieving haemostasis in several ENT procedures. Formulated from self-assembling peptides (SAPs), founded at the Massachusetts Institute of Technology (MIT), PuraShield is a ready-to-use, slightly viscous hydrogel available in the form of a prefilled syringe. When in contact with bodily fluids, such as blood, it is able to achieve haemostasis by creating a three-dimensional barrier similar to the human extracellular matrix, which stops bleeding effectively ⁽¹⁾.

PuraShield’s distinctive viscosity and transparency make it particularly suitable for application in narrow spaces, enabling surgeons a clear view to continue procedures. Additionally, its key features offer tangible benefits for both patients and hospitals by minimising patient discomfort, and potentially, the formation of adhesions, often associated with using traditional packing methods. Overall this may lead to shorter hospital stays and a reduction in the total cost of care ⁽²⁾.

In the ENT field, PuraShield is indicated for a range of surgical procedures, including but not limited to adult tonsillectomy, FESS (Functional Endoscopic Sinus Surgery) and TORS (Trans-oral robotic surgery) for sinus, oral and neck surgeries, as well as rhinoplasty for plastic surgery.

Set to be available from April 2024 in the Spanish market in 3 mL and 5 mL volumes, PuraShield’s launch marks the beginning of a fresh new partnership with the local distributor Prim, through which 3-D Matrix will ensure a solid distribution network for the hydrogel solution throughout the Spanish market.

PuraShield’s launch also marks a significant milestone for the Company which keeps expanding its product portfolio and pipeline in different medical specialities, continuing to leverage the valuable collaboration with its distributor partners across the World.

Please note availability of this product may vary from one Country or Region to another, due to specific local regulatory approval or clearance requirements for sales.

Click here to read more about PuraShield.

A systematic review of PuraStat for treating and preventing gastrointestinal bleeding

3dm-events@puramatrix.com (3-D Matrix) — Fri, 06 Oct 2023 09:30:00 GMT

A systematic review on PuraStat’s safety and efficacy in treating and preventing bleeding in the gastrointestinal tract was recently conducted and presented as an abstract at the European Society of Gastrointestinal Endoscopy Congress 2023 in Dublin.

Methods:
An independent systematic search was conducted in major electronic databases and in proceedings from major congresses. All eligible prospective and retrospective studies describing the endoscopic use of PuraStat ⁽¹⁾were considered. Primary outcomes evaluated rates of successful initial haemostasis, delayed bleeding, and rebleeding. Secondary outcomes were: adverse events, ease of use, and quantity of substance required.

Results:
A total of 3 randomised controlled trials and 14 observational studies were analysed. The overall success rate for haemostasis was 87.7 %, regardless of bleeding aetiology or associated treatments. Rebleeding rate average was 4.7 % (ranging from 0 - 16.2 %), and the overall delayed bleeding rate was 5.02 % (ranging from 0 - 15.91 %).

The volume of gel required varied based on purpose (haemostasis or prophylaxis) with the mean volume ranging from 0.43 to 3.7 ml. PuraStat ease of use was noted by most authors.

Conclusions:
The authors conclude that their review suggests a high efficiency and good safety profile of PuraStat in gastrointestinal endoscopy.

Click here to read the full abstract.

Clinical Evidence on PuraStat’s Efficacy in the Treatment of Haemorrhagic Radiation Proctopathy: A Poster From ESGE 2023

3dm-events@puramatrix.com (3-D Matrix) — Fri, 04 Aug 2023 09:00:00 GMT

Haemorrhagic chronic radiation proctopathy (RP) commonly occurs as epithelial damage to the rectum, caused by radiation therapy in patients treated for pelvic cancers.

There is still no “gold standard” treatment and common treatments have different efficacy levels and complication risks. Despite argon plasma coagulation of telangiectasia being a current choice, its long-term efficacy is uncertain, and side effects occur in up to 20% of patients (e.g., ulcers, strictures, etc).

The poster “Successful treatment of hemorrhagic chronic radiation proctopathy with a novel self-assembling peptide”, presented at ESGE 2023, illustrates the case of a 75-year-old patient with a 30 mm large rectal ulcer with surrounding telangiectasia (treated 4 months post-radiation therapy). PuraStat was applied through a catheter, covering the whole surface of the ulcer and surrounding mucosa with telangiectasia.

The patient underwent 4 therapy sessions with PuraStat (at week 0 – 3 mL, week 3 – 4 mL, week 6 – 1 mL, week 12 – 1 mL). The symptoms and the telangiectasiaimproved at every session, and on week 24 rectoscopy revealed complete mucosal healingⁱ.

From this perspective, PuraStat delivered endoscopically can be seen as a promising and low-risk treatment option, compared to some of the other standard treatment complications.

PuraStat’s safety and efficacy in RP patients were previously investigated and determined in the clinical study “Endoscopically delivered Purastat for the treatment of severe haemorrhagic radiation proctopathy: a service evaluation of a new endoscopic treatment for a challenging condition” by White, K. & Henson, C.C. (2020).

Click here to read the full abstract.

PuraStat’s recommended application techniques and further observations in RP are reported here.

3-D Matrix Summer Update 2023

3dm-events@puramatrix.com (3-D Matrix) — Mon, 31 Jul 2023 09:30:00 GMT

3-D Matrix would like to wish you all a wonderful summer and take this opportunity to remind you that our service remains available as always during all summer months.

As a medical device company, we continue to provide our customers and partners with full service and support.

Should you need or require any information about our products, please send us an e-mail at infoeu@puramatrix.com orvisit our contact page.

A Meta-Analysis Proves PuraStat Efficacy in Reducing Post-Procedural Delayed Bleeding after Endoscopic Resections of Gastrointestinal Lesions

3dm-events@puramatrix.com (3-D Matrix) — Thu, 08 Jun 2023 10:30:00 GMT

Despite the high technical success rates of endoscopic resections (ER), post-procedural delayed bleeding is still a major complication with rates of 2% to 15%, especially in high-risk situations.

Pilot Study Evaluating PuraStat’s Efficacy in Preventing and Controlling Bleeding During Walled-Off Pancreatic Necrosis Drainage: A Case Series

3dm-events@puramatrix.com (3-D Matrix) — Tue, 23 May 2023 08:30:00 GMT

Bleeding, both intraprocedural and delayed, is one of the most frequent adverse events in the case of endoscopic ultrasound (EUS) guided drainage of walled-off pancreatic necrosis (WOPN) and of direct endoscopic necrosectomy (DEN). When bleeding occurs, its management can pose challenges, mainly because of the difficulties in obtaining effective haemostasis and because of the “extraluminal”/peritoneal location.

A New Retrospective Study Shows PuraBond Benefits in Adult Tonsillectomy

3dm-events@puramatrix.com (3-D Matrix) — Tue, 11 Apr 2023 08:30:00 GMT

Tonsillectomy is one of the most common surgical procedures and accounts for 17% of elective workload. Despite it forming a large part of early surgical training amongst juniors, primary and secondary bleed rates carry significant morbidity and mortality. The national GIRFT study identified an adult tonsillectomy readmission rate of 18.4% with bleeding readmissions at 13.0%.

In the new clinical study “Intra-Operative PuraBond Haemostats: A Comparative Trial in Adult Tonsillectomy” by Michaels J. et al. presented at BACO, The British Academic Conference of Otolaryngology (2023), the authors evaluated PuraBond's efficacy in reducing secondary haemorrhage and readmission for post-operative pain.
In the evaluation, 164 adult tonsillectomy cases were analysed and compared with a trial study of 21 adult tonsillectomies with intra-operative PuraBond (applied at the end of the procedure to the bed of the lesion).

Results were as follows:

Readmission rate:

- 18.9% for untreated cohort (77.4% readmissions for bleeding and the remaining secondary to pain).
- 4.8% for the PuraBond cohort (due to bleeding) with no patients requiring a return to theatre.

Secondary haemorrhage was seen in 14.6% of patients without PuraBond and 4.8% of patients with PuraBond application.

This study demonstrates the benefit of PuraBond as a means of reducing secondary haemorrhage and readmission for pain relief in adults undergoing tonsillectomyⁱ. Further studies are required to strengthen this data with additional analysis of post-operative pain between cohorts.

For application within ENT, PuraBond is indicated for:

Bleeding from small blood vessels and oozing from capillaries of the parenchyma and surrounding tissues of solid organs.
Oozing from vascular anastomoses to native or artificial vessels, on the surface of blood vessels and surrounding tissues.

PuraBond allows more than 95% effectiveness in sustaining haemostasis without
additional treatment in the first 24 hours following ENT procedure.

Click here to read the full poster.

Promising new study evaluating safety and haemostatic efficacy in Endoscopic Retrograde Cholangiopancreatography (ERCP) for Post-Sphincterotomy bleeding

3dm-events@puramatrix.com (3-D Matrix) — Thu, 26 Jan 2023 15:15:33 GMT

Endoscopic sphincterotomy (EST) is often performed before bile duct stone removal or metallic stent deployment under endoscopic retrograde cholangiopancreatography guidance. As an adverse complication, bleeding is commonly encountered.

To stop the bleeding, various techniques may be applied (including epinephrine injection, balloon tamponade, hemoclips application and the novel self-expandable metal stent). Although endoscopic haemostasis can be achieved, there are concerns due to the delicate tissue in this area, the risks of post-ERCP pancreatitis and/or ulcer formation, and the associated high cost.

In the new clinical study “Comparison of Endoscopic Hemostasis for Endoscopic Sphincterotomy Bleeding between a Novel Self-Assembling Peptide and Conventional Technique” (Clin Med. 2023 by Yuki Uba et al.), the authors evaluated the safety and efficacy of PuraStat, haemostatic resorbable hydrogel, for the management of Post-Sphincterotomy bleedings vs conventional techniques. Procedure time and length of hospital stay were also compared. The study included N= 62 patients(26 treated with PuraStat vs 36 treated with conventional haemostatic techniques)with the following results:

Haemostatic efficacy: Comparable: 88.4% PuraStat group vs 72.2% the conventional treatment group
The procedure time was significantly shorter in PuraStat group compared with the conventional treatment group (mean 9.38 min vs mean 15.4 min)
Adverse events were more frequently observed in the conventional treatment group (n = 12) than in the PuraStat group (n = 1)
Mean hospital stay was significantly shorter in PuraStat group (7.8 days) compared with the conventional treatment group (13.8 days)i

The results indicate that PuraStat application for EST bleeding may be safe and effective, and is comparable to the conventional techniques.

The hospital stay duration after initial haemostasis was significantly shorter in the PuraStat group compared with the conventional group. This may be due to the higher rate of acute pancreatitis observed in the conventional group compared with the PuraStat group. However, this explanation should be evaluated by further prospective studies.

Click here to read the article in full.

Corporate and “Meet the experts” events: The winning strategy of 3-D Matrix

3dm-events@puramatrix.com (3-D Matrix) — Mon, 14 Nov 2022 15:39:57 GMT

3-D Matrix continues to be focused on its events strategy with the aim of continuing to develop its presence in the ENT (Ears, Nose and Throat), and Cardiac clinical areas, boosting the penetration of PuraBond in these European markets.