A comparison of technicques to disimpact the fetal head on a second stage caesearean simulator.

BACKGROUND: The rate of second stage caesarean section (CS) is rising with associated increases in maternal and neonatal morbidity, which may be related to impaction of the fetal head in the maternal pelvis. In the last 10 years, two devices have been developed to aid disimpaction and reduce these risks: the Fetal Pillow (FP) and the Tydeman Tube (TT). The aim of this study was to determine the distance of upward fetal head elevation achieved on a simulator for second stage CS using these two devices, compared to the established technique of per vaginum digital disimpaction by an assistant. METHODS: We measured elevation of the fetal head achieved with the two devices (TT and FP), compared to digital elevation, on a second stage Caesearean simulator (Desperate Debra ™ set at three levels of severity. Elevation was measured by both a single operator experienced with use of the TT and FP and also multiple assistants with no previous experience of using either device. All measurements were blinded RESULTS: The trained user achieved greater elevation of the fetal head at both moderate and high levels of severity with the TT (moderate: 30mm vs 12.5mm p<0.001; most severe: 25mm vs 10mm p<0.001) compared to digital elevation. The FP provided comparable elevation to digital at both settings (moderate: 10 vs 12.5mm p=0.149; severe 10 vs 10mm p=0.44). With untrained users, elevation was also significantly greater with the TT compared to digital elevation (20mm vs 10mm p<0.01). However digital disimpaction was significantly greater than the FP (10mm vs 0mm p<0.0001). CONCLUSION: On a simulator, with trained operators, the TT provided greater fetal head elevation than digital elevation and the FP. The FP achieved similar elevation to the digital technique, especially when the user was trained in the procedure.

Reloadable Stapler Use during Peripartum Hysterectomy for Placenta Accreta Spectrum: A Novel Surgical Technique and Case Series.

OBJECTIVE: This study aimed to describe a novel surgical technique for the management of antenatally suspected placenta accreta spectrum (PAS). STUDY DESIGN: This is a retrospective, case series of patients with suspected PAS undergoing peripartum hysterectomy with a reloadable articulating stapler at a tertiary care center. RESULTS: Eighteen patients with antenatally suspected PAS were identified and underwent peripartum hysterectomy with the aid of a reloadable stapler. Mean gestational age at delivery was 344/7 ± 11/7 weeks. Mean total operative time (skin-to-skin) was 117.3 ± 39.3 minutes, and 79.8 ± 19.8 minutes for the hysterectomy. Mean blood loss for the entire case was 1,809 ± 868 mL. Mean blood loss for the hysterectomy was 431 ± 421 mL. Mean units of intraoperative red blood cells transfused was 3 ± 1 units. Mean units of postoperative red blood cells transfused was 1 ± 0.5 units. Five cases were complicated by urological injury (two intentional cystotomies). Four patients were admitted to the intensive care unit (ICU) for a mean of ≤24 hours. Mean postoperative LOS was 4.11 ± 1.45 days. Three patients had final pathology that did not demonstrate PAS while four were consistent with accreta, six increta, and five percreta. CONCLUSION: Use of a reloadable articulating stapler device as part of the surgical management of antenatally suspected PAS results in a shorter operative time (117 ± 39 minutes vs. 140-254 minutes previously reported), lower average blood loss (1,809 ± 868 mL vs. 2,500-5,000 mL previously reported) and shorter LOS (4.11 ± 1.45 days vs. 9.8 ± 13.5 days previously reported) compared with traditional cesarean hysterectomy. The reloadable stapling device offers an advantage of more rapidly achieving hemostasis in the surgical management of PAS. KEY POINTS: · PAS is associated with severe maternal morbidity.. · Decreased operative time and blood loss have many clinical benefits.. · Reloadable stapler use for PAS decreases operative time.. · Reloadable stapler use for PAS decreases operative blood loss..

Needle in the heart: a rare case of cardiac tamponade caused by a migrated foreign body and mimicking ST segment elevation myocardial infarction.

BACKGROUND: Pericardial tamponade is a serious condition which may eventually lead to severe haemodynamic disturbances and cardiac arrest. It is most often caused by the accumulation of fluid inside the pericardium, as a result of different aetiological factors such as pericarditis, neoplastic diseases, lymphatic dysfunctions, or idiopathic pericardial disease. Pericardial tamponade can develop after cardiac surgical procedures or as a complication of myocardial infarction. Collection of blood inside the pericardial sack can be the result of pericardial or cardiac trauma. It is exceedingly rare for the injury to be caused by a migrating foreign body. Although a typical picture of pericardial tamponade has been previously described, the disorder may clinically resemble an acute myocardial infarction. CASE PRESENTATION: We report the case of a 58-year-old female patient complaining of new onset thoracic pain and shortness of breath. Electrocardiographic examination results were suggestive of an acute inferior myocardial infarction. However, echocardiography revealed significant pericardial tamponade. The cause was found to be a needle which remained inside the pelvis following a previous cesarean delivery, which the patient had undergone 18 years prior. In emergency setting, the needle was removed and the pericardial tamponade was resolved. Due to the prompt and efficient management, the patient had an uneventful postoperative recovery and presented no recurrence at the follow-up examinations. CONCLUSIONS: The migration of foreign bodies through tissues is exceedingly rare. If present, it may cause life-threatening complications. Since the aetiology of pericardial tamponade is vast, a thorough assessment is highly important. Therefore, echocardiography is the imaging modality of choice. We wish to highlight the possibility of migrating foreign bodies as probable cause for pericardial tamponade, as well as the importance of echocardiographic methods in the fast-track evaluation of such critical conditions.

Effectiveness of the fetal pillow to prevent adverse maternal and fetal outcomes at full dilatation cesarean section in routine practice.

INTRODUCTION: The fetal pillow has been suggested to reduce maternal trauma and fetal adverse outcomes when used to disimpact the fetal head at full dilatation cesarean section. MATERIAL AND METHODS: We performed a retrospective cohort study of the use of the fetal pillow device at full dilatation cesarean section between September 2014 and March 2018 at Liverpool Women's Hospital, a large UK teaching hospital. RESULTS: There were 471 cases of full dilatation cesarean section during the study period and 391 were included for the analysis; 170 used the fetal pillow and 221 were delivered without. We did not demonstrate any benefit in the significant maternal outcomes of estimated blood loss >1000 mL or >1500 mL, need for blood transfusion, or duration of hospital stay, from the use of the fetal pillow. We did not demonstrate any improvement in fetal outcome following use of the fetal pillow for arterial pH <7.1, Apgar score <7 at 5 minutes or admission to the neonatal unit. For deliveries undertaken at or below the level of the ischial spines there was likewise no benefit from fetal pillow use, except in a reduced risk of an arterial pH <7.1 (relative risk 0.39, 95% CI 0.20-0.80, P = .01); however, admission to the neonatal unit was unaffected. CONCLUSIONS: This is the largest study to date on the use of the fetal pillow at full dilatation cesarean section. We did not demonstrate any statistically significant benefit from the use of the fetal pillow to prevent any maternal or fetal adverse outcomes at full dilatation cesarean section in routine clinical use. Further randomized studies are required to prove clinical benefit from this device before more widespread use.

Comparison of outcomes at full-dilation cesarean section with and without the use of a fetal pillow device.

OBJECTIVE: To identify whether use of the fetal pillow device resulted in a reduction in intraoperative complications, such as uterine incision extension, requirement for breech extraction, etc. Other maternal outcomes (duration of hospital stay, requirement for blood transfusion, and requirement for return to hospital or operating theatre) were also reviewed. Neonatal outcomes of APGAR-5, arterial pH, and requirement for intensive care admission were assessed. METHODS: A retrospective cohort analysis was completed for fully dilated cesarean deliveries completed between January 2014 and December 2018 at Ipswich Hospital, Australia. In total, 174 patient records were identified (114 with pillow, 60 without). Logistic and linear regressions were used to assess the outcomes associated with fetal pillow use. RESULTS: There were no significant differences in operative complications between the pillow and no-pillow groups (odds ratio [OR] 0.56, 95% confidence interval [CI] 0.26-1.22, P=0.146). Linear regression analysis showed a decrease in hospital length of stay (hours) (-9.4, 95% CI -17.80 to -0.99, P=0.029) and a higher neonatal arterial pH at delivery (0.06, 95% CI 0.03-0.09, P=0.0001) in the pillow group. CONCLUSION: At full dilation cesarean, operative complications are not increased when employing the fetal pillow with maternal benefits of decreased hospitalization.

Cephalic Elevation Device for Second-Stage Cesarean Delivery: A Randomized Controlled Trial.

OBJECTIVE: A cephalic elevation device is an inflatable device that elevates the fetal head. We sought to evaluate whether such a device reduces time to delivery after hysterotomy and lowers morbidity in cesarean deliveries during the second stage of labor. METHODS: We conducted a double-blind randomized controlled trial among nulliparous, term women aged 18-50 years with vertex singleton pregnancies. Women were eligible if they were to undergo cesarean delivery in the second stage of labor. All participating women had the cephalic elevation device inserted by the delivering provider and were randomly allocated to inflation or noninflation of the device. Inflation was performed in a blinded fashion. The primary outcome was time from hysterotomy to delivery. A sample size of 30 per group (N=60 participants) was planned to detect a 50% decrease in time to delivery after hysterotomy with cephalic elevation device inflation. RESULTS: From January 2018 through July 2019, 60 women who underwent cesarean delivery in the second stage were randomized. Analysis was by intention to treat. Women in the inflation group were older (33 vs 30.5 years), but the groups were otherwise similar. In both groups, most women had a low-transverse hysterotomy (93%). The median time from hysterotomy to delivery was significantly shorter in the inflation group (31 vs 54 seconds; P<.01). There was no significant difference in neonatal outcomes. CONCLUSION: Use of the cephalic elevation device during second-stage cesarean delivery led to a 23-second reduction time from hysterotomy to delivery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03342508. FUNDING SOURCE: The cephalic elevation devices used in this study were donated by Safe Obstetrics Systems.

Operative Technique and Experience of One Referral Center With Vaginal Cesarean Delivery.

BACKGROUND: To report the experience of vaginal cesarean delivery and describe the surgical technique. METHOD: This is a retrospective case series from one referral center of patients who underwent vaginal cesarean delivery from 2000 to 2017, presenting a step-by-step operative technique with a video. The operative technique consists of: 1) development of a transvaginal bladder flap by dissecting the bladder off the cervix, thereby exposing the lower uterine segment; 2) making a vertical segment incision up to the highest part of the lower uterine segment, just below the muscular portion of the uterus; 3) extraction of the fetus; and 4) reconstruction of the lower uterine segment and vagina. EXPERIENCE: Seven patients with maternal indications for urgent premature delivery who underwent vaginal cesarean delivery were included. Indications were severe bleeding (n=3), severe previable preeclampsia (n=2), severe heart failure (n=1), and stroke (n=1). The average gestational age at delivery was 21 2/7 weeks (18 2/7-24 1/7 weeks); median fetal birth weight was 300 g (179-500 g). There were no intraoperative complications attributable to the procedure. CONCLUSION: Vaginal cesarean delivery is a valuable technique for rapid fetal extraction of deceased or nonviable fetuses for severe maternal indications.

Early versus delayed removal of indwelling catheters in patients after elective cesarean section: a prospective randomized trial.

Purpose: We conducted a prospective randomized controlled trial to compare postoperative urinary catheter removal 2 versus 12 h after elective cesarean section in terms of irritative symptoms, first void time, incidence of urinary tract infection, postoperative mobilization time, and hospitalization time.Methods: A total of 134 women admitted to Duzce University Hospital for primary or recurrent elective cesarean section were randomized into two groups. A total of 62 women were enrolled in the early group, with indwelling catheter removal 2 h after cesarean section; 74 women were enrolled in the delayed group, with catheter removal 12 h after the cesarean section. The groups were prospectively compared in terms of irritative urinary symptoms, bacteriuria, hematuria, length of hospital stay, and mobilization time.Results: Urinary frequency (p = .04), microscopic hematuria incidence (p = .04), postoperative mobilization time (p = .01), and length of hospital stay (p = .009) were significantly lower in the early group than in the delayed group. There were no significant differences in terms of bacteruria, urinary retention, dysuria, and first postoperative voiding time.Conclusions: Early removal of urinary catheters after elective cesarean section is associated with reduced mobilization time and hospital stay.

Tissue Adhesive Compared With Sterile Strips After Cesarean Delivery: A Randomized Controlled Trial.

OBJECTIVE: To assess whether tissue adhesive after closure of Pfannenstiel incision for cesarean delivery lowers the risk of wound complications when compared with sterile strips. METHODS: In this multicenter randomized controlled trial, women undergoing cesarean delivery using Pfannenstiel skin incision were randomized to receive tissue adhesive (2-octyl cyanoacrylate) compared with sterile strips after closure of the skin incision. The primary outcome was a composite of wound complications (drainage, cellulitis, abscess, seroma, hematoma, or isolated wound separation) within 8 weeks of delivery. Secondary outcomes included operative time, readmission, office or emergency department visits, or antibiotic use for wound complications, and patient satisfaction with the cesarean scar. With 80% power and a 95% CI, a sample size of 432 per group (n=864) was required to detect a 50% reduction in the primary outcome. A planned interim analysis was performed after 500 patients delivered. A conditional power analysis revealed that the probability of showing a benefit with tissue adhesive was extremely low (6.2%), and the study was halted owing to futility. RESULTS: Between November 2016 and April 2018, 504 patients were randomized, and follow-up was achieved in 479 (95%). Wound complications occurred in 18 out of 238 patients (7.6%) in the tissue adhesive group and 19 out of 241 patients (7.9%) in the sterile strips group (relative risk 0.96; 95% CI 0.51-1.78). There were no significant differences with regard to types of wound complications, operative time, readmission, office or emergency department visits, antibiotics prescribed for wound complications, or patient scar assessment scores of pain, stiffness, and irregularity between the two groups. However, tissue adhesive performed slightly better in regard to itchiness of scar and overall scar satisfaction. CONCLUSION: Compared with sterile strips, tissue adhesive after closure of Pfannenstiel incision for cesarean delivery is unlikely to lower the risk of wound complications. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02838017.

Preparing Perinatal Nurses for Obstetric OR Emergencies by Using Simulations.

A cesarean hysterectomy (CH) is an emergency procedure that can save a woman's life in the event of postpartum hemorrhaging. If the CH is anticipated, it can take place in the general OR; however, more complex patients with multiple comorbidities are undergoing cesarean deliveries, resulting in unanticipated CHs and emergent procedures occurring in the obstetric OR. Many perinatal nurses believe they are not properly trained to provide the level of perioperative care required during a CH. Perinatal nurse leaders implemented a perinatal perioperative simulation program to address this knowledge gap. Feedback from perinatal nurses after completing the simulation revealed they gained a comprehensive understanding of the flow of the procedure and the instrumentation needed to perform it. The simulation also improved communication and leadership skills in the obstetric OR. Simulations may help perinatal nurses provide safer, higher quality care when a delivery develops into a high-risk operative procedure.

Scalpel versus diathermy skin incision in Caesarean section.

Surgical scalpels are traditionally used for skin incisions during a Caesarean delivery; the great evolutions in electrosurgical devices bring an alternative method for skin incision by the usage of cutting diathermy. This was a prospective randomised comparative study conducted during the period from March 2016 to February 2017 on 200 patients, 100 patients had skin incisions using the surgical scalpel, while 100 patients had skin incisions with a diathermy, in order to judge the variations in the postoperative pain, the incision time, the incision blood loss, the operative time, the wound healing and the wound complications. We observed a significant difference between the two groups regarding the incision time (p < .001), incisional blood loss (p < .001), operative time (p < .001) and the postoperative pain (p < .001), where these parameters were less in the diathermy group. No significant difference observed between the two groups regarding the wound healing (p = .389) and wound complications (p = .470). We can conclude that the proper usage of diathermy in making the skin incision during a Caesarean section in this study achieved better results than the scalpel incision. Impact statement What is already known on this subject? Surgical scalpels are traditionally used in making the skin incisions during a Caesarean section; diathermy incisions, on the contrary, are less popular among the surgeons. It has been hypothesised that the application of extreme heat may result in a significant postoperative pain and poor wound healing. There has been a widespread use of diathermy for hemostasis but fear of production of large scars and improper tissue healing has restricted their usage in making skin incisions. What do the results of this study add? The use of diathermy for skin incisions in Caesarean section in this study was associated with a reduced incisional blood loss, incisional time, operative time and postoperative pain. It had no effect on wound closure and was not associated with any delay in wound healing. Also, the wound complications rate was equal in both types of incisions. What are the implications of these findings for clinical practice and/or further research? Most surgeons prefer the scalpel in making skin incision during a Caesarean section due to the fear of surgical site infection. Our findings proved different, we proved that cutting diathermy could be accepted as an alternative technique for making a skin incision without increased rates of wound infections. Also, the advantages of cutting diathermy will give benefits to both the patients and the surgeons.

Cesarean section scar in 3 T magnetic resonance imaging and ultrasound: image characteristics and comparison of the methods.

PURPOSE: Uterine rupture during labor is a rare but life-threatening complication after previous cesarean section (CS). Prenatal risk is assessed using ultrasound thickness measurement of the lower uterine segment (LUS). Due to inhomogeneous study results, however, clinical obstetrics still lacks for standard protocols and reliable reference values. As 3 T magnetic resonance imaging (MRI) has not yet been sufficiently studied regarding LUS diagnostics after previous CS, we sought to evaluate its feasibility focusing on thickness measurements and typical characteristics of the CS-scar region in comparison to ultrasound and the intraoperative status. METHODS: In this prospective study, 25 asymptomatic patients with one previous CS and inconspicuous ultrasound findings were included. An additional 3 T MRI with either a T2-weighted Turbo-Spin-Echo or a Half Fourier-Acquired-Single-shot-Turbo-spin-Echo sequence in a sagittal orientation was performed. We analyzed categorical image quality, inter- and intra-rater reliability as well as anatomy, morphology and thickness of the LUS. Results were compared to ultrasound and intraoperative findings. RESULTS: MRI provided good to excellent image quality in all patients. The imaged structures presented with a high variability in anatomy and morphology. Image characteristics indicating the uterine scar were only found in 11/25 (44%) patients. LUS thickness measurements with MRI showed good inter- and intra-rater reliability but poor agreement with ultrasound. CONCLUSIONS: MRI is appropriate for additional LUS diagnostics in patients with previous CS. The strong individual variability of LUS-anatomy and morphology might explain the difficulties in establishing uniform diagnostic standards after CS.

The use of O-ring retractors at Caesarean section : A systematic review and meta analysis.

O-ring retractors (Alexis/Mobius) have been shown to reduce the risk of Surgical site infection (SSI) following general abdominal surgery. The benefit at caesarean section (CS) remains to be established given the relatively high cost. OBJECTIVES: To assess the efficacy of O-ring retractors when used at CS. STUDY DESIGN: Systematic review and meta-analysis. Electronic databases were searched from inception of each database until January 2018. No language restrictions were applied. All randomised controlled trials (RCTs) which compared the use of an O-ring retractor to routine care at CS were included. Primary outcome was SSI. Secondary outcomes were operating time, estimated blood loss, need for blood transfusion, need to exteriorise the uterus, requirement for additional postoperative analgesia and adequate operative field visualisation. Analysis was performed using Revman 5.3. RESULTS: 6 RCTs were included in the qualitative synthesis and the meta-analysis. This included 1669 women. The use of O-ring retractors did not reduce the risk of SSI when used at CS RR 0.76 (95% CI 0.34-1.70). Nor did the use of O-ring retractors reduce the operating time, estimated blood loss, the need for blood transfusion or the need for additional postoperative analgesia. The use O-ring retractors did reduce the need for exteriorisation of the uterus RR 0.48 (95% CI 0.33-0.69), and did increase the rate of adequate visualisation of the operative field RR 1.05 (95% CI 1.00-1.10). In a planned subgroup analysis there was a reduction in the rate of SSI with the use of O-ring retractors in women with a BMI < 35 RR 0.34(95% CI 0.12-0.98). CONCLUSION: This review has shown that O-ring retractors do not reduce the incidence of the common measurable complications of CS; SSI, blood loss, need for blood transfusion and need for additional postoperative analgesia. There may be a subgroup where these retractors are useful, but present evidence does not justify their routine use at CS.

Effect of table tilt and spine flexion-rotation on the acoustic window of the lumbar spine in pregnant women / Efeito da inclinação da mesa e flexão da coluna sobre a janela acústica da coluna lombar em mulheres grávidas

Abstract Study objective: The purpose of this study was to assess whether application of dorsal table tilt and body rotation to a parturient seated for neuraxial anesthesia increased the size of the paramedian target area for neuraxial needle insertion. Setting: Labor and Delivery Room. Patients: Thirty term pregnant women, ASA I-II, scheduled for an elective C-section delivery. Interventions: Lumbar ultrasonography was performed in four seated positions: (F) lumbar flexion; (FR) as in position F with right shoulder rotation; (FT) as in position F with dorsal table-tilt; (FTR) as in position F with dorsal table-tilt combined with right shoulder rotation. Measurements: For each position, the size of the 'target area', defined as the visible length of the posterior longitudinal ligament was measured at the L3-L4 interspace. Main results: The mean posterior longitudinal ligament was 18.4 ± 4 mm in position F, 18.9 ± 5.5 mm in FR, 19 ± 5.3 mm in FT, and 18 ± 5.2 mm in FTR. Mean posterior longitudinal ligament length was not significantly different in the four positions. Conclusions: These data show that the positions studied did not increase the target area as defined by the length of the posterior longitudinal ligament for the purpose of neuraxial needle insertion in obstetric patients. The maneuvers studied will have limited use in improving spinal needle access in pregnant women.

Resumo Objetivo do estudo: O objetivo deste estudo foi avaliar se a inclinação lateral da mesa cirúrgica e a rotação do corpo de uma parturiente sentada para anestesia neuraxial aumentou o tamanho da área-alvo paramediana para a inserção da agulha neuraxial. Ambiente: Sala de parto. Pacientes: Trinta grávidas a termo, ASA I-II, agendadas para cesárea eletiva. Intervenções: Ultrassonografia lombar foi feita em quatro posições sentadas: (F) flexão lombar; (FR) como na posição F com rotação do ombro direito; (FT) como na posição F com inclinação lateral da mesa cirúrgica; (FTR) como na posição F com inclinação lateral da mesa cirúrgica combinada com a rotação do ombro direito. Mensurações: Para cada posição, o tamanho da "área-alvo", definido como o comprimento visível do ligamento longitudinal posterior, foi medido no interespaço de L3-L4. Principais resultados: As médias do ligamento longitudinal posterior foram: 18,4 ± 4 mm na posição F; 18,9 ± 5,5 mm na posição FR; 19 ± 5,3 mm na posição FT e 18 ± 5,2 mm na posição FTR. O comprimento médio do ligamento longitudinal posterior não foi significativamente diferente nas quatro posições. Conclusões: Esses dados mostram que as posições avaliadas não aumentaram a área-alvo, conforme definido pelo comprimento do ligamento longitudinal posterior com o objetivo de inserção da agulha neuraxial em pacientes obstétricas. As manobras avaliadas terão um uso limitado na melhoria do acesso à agulha espinhal em mulheres grávidas.

Comparative cosmetic outcome of surgical incisions created by the PEAK Plasma Blade and a scalpel after cesarean section by Patient and Observer Assessment Scale (POSAS): A randomized double blind study.

OBJECTIVE: To compare the cosmetic result of the PEAK Plasma Blade with traditional scalpel in patients who had primary cesarean delivery by using POSAS (Patient and Observer Assessment Scale). MATERIAL AND METHODS: Fourty women between 20 and 40 years, who were planning to have primary cesarean delivery, were randomized for skin incision with PEAK Plasma Blade (n:20) and with scalpel (n:20) were blinded to their group allocation. At six months, the cosmetic outcome of the cesarean scar was assessed using the POSAS. Subjective scar rating was performed using the patient component of the POSAS. Objective scar assessment was performed by an observer dermatologist blinded to the patient's group allocation. RESULTS: The observer scores (p = 0,003), patient scores (p = 0,001) and the total scores (p = 0,001) of the POSAS scale were significantly lower in favor of the Peak Plasma Blade group with respect to the scalpel group. CONCLUSION: The PEAK Plasma Blade has superior cosmetic outcome compared to traditional scalpel skin incision at cesarean section.

Medical Devices; Obstetrical and Gynecological Devices; Classification of the Fetal Head Elevator. Final order.

The Food and Drug Administration (FDA or we) is classifying the fetal head elevator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the fetal head elevator's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.