DIGESTIVE, GASTROINTESTINAL & Hepatology ASC THERAPIES & PROCEDURES

WHAT WE OFFER

Our diverse portfolio of innovative, high-quality products and reliable therapies means that when a patient comes to your ASC, you can choose the right product or therapy for the patient at the right time.

Below are available products and services to assist you and your ASC designed for digestive, gastrointestinal, and hepatology procedures, including:

GASTRIC ELECTRICAL STIMULATION

Gastric electrical stimulation with the Medtronic Enterra™ system helps control the chronic nausea and vomiting associated with gastroparesis* by stimulating the smooth muscles of the lower stomach.

Prospective clinical studies show that gastric electrical stimulation may significantly reduce vomiting frequency in patients with gastroparesis of idiopathic or diabetic origin.1 Gastric electrical stimulation may also deliver significant improvement in health-related quality of life.1

Close-up Photo of Enterra Two System

Enterra™ II System

The Enterra™ II gastric neurostimulator is a programmable device that generates mild electrical pulses for gastric electrical stimulation to treat chronic, intractable nausea and vomiting due to gastroparesis.*

This small, battery-powered gastric neurostimulator is implanted beneath the skin in the lower abdominal region. The neurostimulator generates controlled electrical pulses delivered by leads to the antrum portion of the stomach muscle wall. After implant, the clinician optimizes therapy for the patient with a clinician programmer.

The Medtronic Enterra Therapy System for gastric electrical stimulation (GES) is indicated for use in the treatment of chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years.

Indications, Safety, and Warnings

Learn about Enterra
Close-up Photo of Barrx Product

GASTROINTESTINAL RADIOFREQUENCY ABLATION

We offer a comprehensive portfolio of radiofrequency ablation solutions to treat Barrett's esophagus and other GI tract diseases.2-7 With focal and circumferential catheters, these innovations provide the flexibility needed to meet the unique needs of each patient.

The Barrx™ system is designed to remove the Barrett's epithelium in a short, well-tolerated endoscopic procedure and offers an alternative to "watchful waiting" for patients with intestinal metaplasia, low-grade, and high-grade dysplasia.2-7

LEARN MORE ABOUT GASTROINTESTINAL RADIOFREQUENCY ABLATION
Close-up Photo of Emprint SX Ablation platform

Emprint™ ablation system (with Thermosphere technology)

EMPRINT™ SX IS THE FIRST AND ONLY INTEGRATED ABLATION PLATFORM WITH REAL-TIME 3-D ULTRASOUND NAVIGATION

The Emprint™ SX ablation platform is a cutting-edge, integrated ultrasound navigation and ablation platform that reduces procedural complexity and has been shown to improve the targeting accuracy of non-resectable liver tumors ablation.

  • Navigation software has been shown to improve successful antenna placement versus standard ultrasound guidance upon first attempt.8
  • 3-D visualization of the potential ablation zone helps ensure complete coverage of the target.9
  • Thermosphere™ technology creates predictable, spherical ablation zones.10
  • Intuitive interface with a step-by-step guided setup and context-sensitive troubleshooting, makes the system easy to use.11
LEARN MORE ABOUT GASTROINTESTINAL THERMOSPHERE™ ABLATION
Close-up Photo of HET bipolar system

HEMORRHOID TREATMENT

Non-surgical treatment for symptomatic grades I and II internal hemorrhoids. The HET™ bipolar system is a gentle, simple, and efficient12,14 non-surgical treatment method for symptomatic grades I and II internal hemorrhoids.

Its design allows treatment in one procedure. The treatment targets the area above the dentate line and its low treatment temperature minimizes collateral tissue damage.13

Hemorrhoid Energy Therapy, using the HET™ bipolar system can be completed quickly with minimal pain to the patient.12,14

LEARN MORE ABOUT HET™ BIPOLAR SYSTEM
Close-up Photo of Beacon System

ENDOSCOPIC ULTRASOUND 

The Beacon™ EUS delivery system features interchangeable FNA and FNB needles designed to support consistent and predictable acquisition of tissue samples with intact cellular architecture.15-19

  • The components of this innovative EUS delivery system are interchangeable, supporting greater efficiency,20 while built-in safety features help protect healthcare staff from needle stick injury. And with advanced SharkCore™ needles that help improve biopsy yield,16-20 interventional endoscopists and pathologists can potentially increase diagnostic rates.15-19
LEARN MORE ABOUT BEACON™
Close-up Photo of Bravo reflux testing system

BRAVO™ CALIBRATION-FREE REFLUX TESTING SYSTEM

The Bravo™ reflux testing system is an innovative solution that allows physicians to evaluate the frequency and duration of acid reflux in order to better understand patients’ symptoms.18

With up to a 96-hour monitoring period, the Bravo™ reflux increases the likelihood that subjects will develop symptoms during the study for symptom association
evaluation.19

LEARN MORE ABOUT BRAVO™

PATIENT OUTREACH TOOLS

Enterra™ therapy may help to control symptoms of chronic nausea and vomiting associated with gastroparesis* caused by diabetes or an unknown origin in patients aged 18-70 years.

REIMBURSEMENT & CODING TOOLS

These downloadable documents provide general coverage and reimbursement information for a variety of digestive & gastrointestinal healthcare services.

Currently we offer the following information regarding coding and reimbursement.

The documents listed below provide general reimbursement information to assist in obtaining coverage and reimbursement for healthcare services.

Medical necessity will dictate site of service for each individual patient. Physicians should confirm inpatient or outpatient admission criteria before selecting site of service.

*

Humanitarian Device: The Enterra Therapy system for gastric electrical stimulation is authorized by Federal law for use in treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology. The effectiveness of this device for this use has not been demonstrated. What does this mean?

1

Abell T, McCallum R, Hocking M, et al. Gastric electrical stimulation for medically refractory gastroparesis. Gastroenterology. 2003; 125:421-28.

2

Phoa KN, van Vilsteren FG, Pouw RE, et al. Radiofrequency ablation in Barrett's esophagus with confirmed low-grade dysplasia: interim results of a  European multicenter randomized controlled trial (SURF). Gastroenterology. 2013; 144:S-187. 

3

Shaheen NJ, Sharma P, Overholt BF, et al. Radiofrequency ablation in Barrett's esophagus with dysplasia. N Engl J Med. 2009 May 28;360(22):2277-88.

4

van Vilsteren FG, Pouw RE, Seewald S, Alvarez HL, Sondermeijer CM, Visser M, et al. Stepwise radical endoscopic resection versus radiofrequency ablation for Barrett's esophagus with high-grade dysplasia or early cancer: a multicentre randomised trial. Gut. 2011; 60:765-73.

5

Fleischer DE, Overholt BF, Sharma VK, et al. Endoscopic radiofrequency ablation for Barrett's esophagus: 5-year outcomes from a prospective multicenter trial. Endoscopy. 2010;42:781-

6

Phoa KN, Pouw RE, van Vilsteren FG, et al. Remission of Barrett's esophagus with early neoplasia 5 years after radiofrequency ablation with endoscopic resection: a Netherlands cohort study. Gastroenterology. 2013 Jul; 145(1):96-104.

7

Gray NA, Odze RD, Spechler SJ. Buried metaplasia after endoscopic ablation of Barrett's esophagus: a systematic review. AM J Gastroenterol. 2011;106:1899-908.

8

Sastry, AV, Swet, JH, Murphy KJ, et al. A novel 3-dimensional electromagnetic guidance system increases intraoperative microwave antenna placement accuracy. HPB 2017.

9

AIM Software Design Specification (Internal Document) Jan 2017.

10

Based on Internal report #RE00059555, Emprint™ SX System Bench Tissue Performance Verification. March 2017.

11

Based on internal test report #RE00097926, Validation survey memo. June 2017. 

12

Kantsevoy S, Bitner M. Nonsurgical treatment of actively bleeding internal hemorrhoids with a novel endoscopic device (with video). Gastrointest Endosc, 2013 Oct;78(4):649-653.

13

Piskun G, Tucker R. New bipolar tissue ligator combines constant tissue compression and temperature guidance: histologic study and implications for treatment of hemorrhoids. Med Devices (Auckl). 2012 Oct;5:89-96.

14

Crawshaw BP, Russ AJ, Ermlich BO, Delaney CP, Champagne BJ. Prospective case series of a novel minimally invasive bipolar coagulation system in the treatment of grade I and II internal hemorrhoids. Surg Innov. 2016 Dec;23(6):581-585.

15

Based on product development testing data. Data on file. (See Report #1085 and Report #1090).

16

Schulman A, Thompson C, Chan W, Ryou M. Optimizing EUS-guided liver biopsy sampling: comprehensive assessment of needle types and tissue acquisition techniques. Gastrointestinal Endoscopy, 2017;85(12):419-426.

17

DiMaio C, Kolb J, Benias P, et al. Initial experience with a novel EUS-guided core biopsyneedle (SharkCore): results of a large North Americanmulticenter study. Endoscopy International Open,2015;4:E974-E979.

18

Kothari S, Kothari T, Zhou Z, et al. #Tu1648Evaluating the Efficacy of a New FDA Approved EUS Core Biopsy Needle and Different Fine Needle Biopsy (FNB) Techniques to Yield the Best Core Specimen in a Live Porcine Model. Gastrointestinal Endoscopy,2015;81(5S):AB544.

19

Schulman A, Chan W, Thompson C,Ryou M. #Su1984 A Novel EUS-guided Liver Biopsy Needle is Superior to Gold Standard Percutaneous Needle: Examining the Effect of Needle Design and Number of Excursions on Histologic Yield. Gastrointestinal Endoscopy,2016;83(5s):AB416.

20

Enestvedt B, Maranki, J, Makipour K, Mathur M, Haluszka O. Is Two Better Than One? a Comparison of EUS-FNA Efficiency of Single- vs Multi-Needle Platforms. Gastrointestinal Endoscopy. 2013;77(5S):AB179.

21

Sifrim D, Castell D, Dent J, Kahrilas PJ. Gastro-oesophageal reflux monitoring: review and consensus report on detection and definitions of acid, non-acid, and gas reflux. Gut. 2004;53(7):1024-1031. Page 1030.

22

Richter J, Pandolfino J, Vela M, et al. Utilization of wireless pH monitoring technologies: a summary of the proceedings from the Esophageal Diagnostic Working Group. Disease of the Esophagus, 2012 August 7.