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PubMedDate not supplied

Current options for mechanical heart technology.

Heart transplantation remains the treatment of choice for end-stage heart failure despite limited donor availability and allograft durability. Artificial heart technology was initially developed as a replacement for transplantation but the initial experience with these technologies was disappointing. The quest for a total artificial heart has largely been abandoned in favor of ventricular assist devices (VADs). VADs have gained widespread acceptance as bridge to transplant and bridge to recovery therapy. After more than a decade of clinical use, several FDA approved device designs have proved effective in treating patients with various causes of heart failure. This review describes the current, clinically available ventricular replacement and assist devices and defines the adult patient populations in which they are useful. The next generation of these devices will soon become available and their clinical utility will likely shape the future direction of heart failure therapy. Ultimately the concept of a long-term total artificial heart may be revisited.

Device Approval↗
PubMed2026

An impact assessment of the European medical device regulations implementation - the current status quo.

BACKGROUND: This research aims to assess the current impact of the medical and in-vitro diagnostic devices regulations (MDR/IVDR) on the device industry in the EU, under the lens of postimplementation and the amending regulation, and in advance of the final transition to the IVDR/MDR in the future. RESEARCH DESIGN AND METHODS: A quantitative survey was administered to a diverse cohort of medical device enterprises, ranging from micro to large organizations. RESULTS: The survey indicates that the MDR/IVDR has harmed innovation, leading many manufacturers to seek initial device approval and launch elsewhere before in Europe. There is evidence that some manufacturers have rationalized their existing product portfolios and removed devices from the market as they stated they would in previous industry surveys. The MDR/IVDR has been shown to negatively impact manufacturers, with increased costs related to notified body (NB) fees, maintaining and updating documentation, recertification fees, and hiring additional staff. CONCLUSION: This study provides a current status of the effects of MDR/IVDR on manufacturers and finds that despite amending regulations and other interventions taken by the EU to mitigate regulatory burden, ensure product availability, and address stakeholder concerns, the EU is no longer the market of choice for new products.

Equipment and Supplies↗
PubMed2002

Advances in endometrial ablation.

UNLABELLED: The evolution of the surgical treatment of dysfunctional uterine bleeding has resulted in the design and manufacture of instrumentation that is minimally invasive, has a low risk profile, and is technically simple to operate. Whereas hysterectomy was the only definitive surgical option before 1981, operative hysteroscopy with transcervical resection of the endometrium and rollerball ablation of the endometrium gained favor in the mid-1980s and 1990s. During the past 10 years, devices dedicated entirely to the ablation (or destruction) of the endometrium have been designed, modeled, tested, and approved for clinical use in the United States. This review describes the methods by which the technologies are evaluated and approved for clinical use by the Food and Drug Administration. In addition, the reported efficacy of each approved device is reviewed. The complications associated with the devices, as well as the potential long-term risks of endometrial ablation, also are reported. Finally, the cost for device disposables and nondisposables is presented. TARGET AUDIENCE: Obstetricians & Gynecologists, Family Physicians LEARNING OBJECTIVES: After completion of this article, the reader will be able to list the various FDA-approved uterine ablation devices, compare the effectiveness of the various uterine ablation devices, and summarize the various adverse events associated with the use of the uterine ablation devices.

Catheter Ablation↗
PubMed2004

Destination therapy with ventricular assist devices.

Despite extensive research and great strides over the past 40 years, the ideal permanent mechanical assist device remains elusive. The incidence of heart failure is increasing, and the number of heart transplants has remained constant. The HeartMate and Novacor are two pulsatile, long-term ventricular assist devices (VADs) commonly used as a bridge to transplantation. Randomized Evaluation of Mechanical Assistance in the Treatment of Congestive Heart Failure is a randomized study of device therapy in heart failure with treatment either with device (HeartMate) therapy or maximal medical therapy which was recently completed and demonstrated a Kaplan-Meier survival rate at 1 year of 52% for the device group compared to 25% in the medical therapy group. The TCI HeartMate is the only device approved for destination therapy, while others such as the Novacor device are in the process of evaluation. Most of these devices are still plagued by mechanical problems, bleeding, thromboembolism and infection. Other promising new devices include smaller VADs using impeller pump technology, such as the Arrow LionHeart, Micromed Debakey pump and Jarvik 2000 pump. The CardioVAD is an interesting chronically implantable balloon pump inserted into the descending thoracic aorta. While experience with the newer implantable pumps is growing, most of them require some manipulation of the heart perioperatively, in addition to anticoagulation postoperatively and careful monitoring for complications and infection.

Cardiotonic Agents↗
PubMed2006

Endovascular abdominal aortic aneurysm repair: long-term outcome measures in patients at high-risk for open surgery.

PURPOSE: The study was conducted to determine the outcome in the United States after endovascular repair (EVAR) of infrarenal abdominal aortic aneurysms (AAAs) in patients at high-risk for open surgery by using independently audited, high-compliance, chart-verified data sets, and to compare those results with open surgery. METHODS: High-risk was defined to match a recent European trial (EVAR2) and included age of > or =60 years with aneurysm size of > or =5.5 cm, plus at least one cardiac, pulmonary, or renal comorbidity. Data from five multicenter investigational device exemption clinical trials leading to Food and Drug Administration (FDA) approval were analyzed. Of 2216 EVAR patients, 565 met the high-risk criteria. Of 342 surgical controls (OPEN), 61 met high-risk criteria. Primary outcome comparisons included AAA-related death, all-cause death, and aneurysm rupture. Secondary measures were endoleak, AAA sac enlargement, and migration. RESULTS: Average age of the high-risk EVAR subset was 76 +/- 7 years vs 74 +/- 6 years OPEN (P = 0.07), mean EVAR AAA size was 6.4 +/- 0.8 cm vs 6.6 +/- 1.0 cm OPEN (P = .33), and average EVAR follow-up was 2.7 years vs 2.5 years OPEN. The 30-day operative mortality was 2.9% in EVAR vs 5.1% in OPEN (P = .32). The AAA-related death rate after EVAR was 3.0% at 1 year and 4.2% at 4 years compared with 5.1% at both time points after OPEN (P = .58). Overall survival at 4 years after EVAR was 56% vs 66% in OPEN (P = .23). After treatment, EVAR successfully prevented rupture in 99.5% at 1 year and in 97.2% at 4 years. CONCLUSIONS: Endovascular repair of large infrarenal AAAs in anatomically suited high-surgical-risk patients using FDA-approved devices in the United States is safe and provides lasting protection from AAA-related mortality. EVAR mortality remained comparable with OPEN up to 4 years. The decision to treat AAAs in patients with advanced age and significant comorbidities must be individualized and carefully considered, but repair provides excellent protection from AAA-related death.

Aged↗
PubMed2001

Impact of exclusion criteria on patient selection for endovascular abdominal aortic aneurysm repair.

PURPOSE: Wide-ranging predictions have been made about the usefulness of endovascular repair for patients with abdominal aortic aneurysms (AAAs). The availability of US Food and Drug Administration-approved devices has removed the restrictions on patient selection, which had been controlled by device trials. This study examined the applicability of endovascular AAA repair and identified the anatomic barriers to successful endovascular AAA repair that should guide future device development. METHODS: All patients who came to our institution for infrarenal AAA repair between April 1998 and June 2000 were offered evaluation for endovascular repair. Thin-cut spiral computed tomography scans and arteriograms were obtained on all patients, and their anatomic characteristics were prospectively entered into a database. A wide selection of available devices allowed the treatment of diverse AAA anatomic features. RESULTS: A total of 307 patients were examined (264 men, 43 women). Of these, 204 patients (66%; 185 men, 19 women) underwent endovascular repair, and 103 patients (34%, 79 men, 24 women) were rejected. Reasons for exclusion included short aneurysm neck (56, 54%), inadequate access because of small iliac arteries (48, 47%), wide aneurysm neck (41, 40%), presence of bilateral common iliac aneurysms extending to the hypogastric artery (22, 21%), excessive neck angulation (14, 14%), extensive mural thrombus in the aneurysm neck (10, 10%), extreme tortuosity of the iliac arteries (10, 10%), accessory renal arteries originating from the AAA (6, 6%), malignancy discovered during the examination (5, 5%), and death during the examination interval (2, 2%). Rejected patients had an average of 1.9 exclusion criteria (range, 1 to 4). A disproportionate number of women were excluded because of anatomic findings (P = .0009). Although 80% of patients who were at low risk for surgery qualified for endovascular repair, only 49% of our patients who were at high risk for surgery were acceptable candidates (P < .001). Of the 103 patients who were excluded, 34 (33%) underwent open surgical repair, and the remaining 69 (67%) were deemed to be unfit for open surgery. Three patients (1.4%) failed endograft placement because of inadequate vascular access. CONCLUSION: Most infrarenal AAAs (66%) can be treated with endovascular devices currently available commercially or through US Food and Drug Administration-approved clinical trials. However, patients who are at high risk for surgery and might benefit most from endovascular repair are less likely to qualify for the procedure (49%). Men (70%) are more likely than women (40%) to meet the anatomic criteria for endografting. Difficulties with vascular access and attachment site geometry predominate as reasons for exclusion. Our findings suggest that smaller profile devices, which can negotiate small and tortuous iliac arteries, are needed. Proximal and distal attachment site problems require devices that can accommodate wide and angulated attachment necks and achieve short seal zones.

Aged↗
PubMed2002

Obstetric and gynecology devices; effective date of requirement for premarket approval for glans sheath devices. Final rule.

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of product development protocol (PDP) for glans sheath medical devices. The agency has previously published its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices.

Contraceptive Devices↗
PubMed2001

Duplex surveillance of abdominal aortic stent grafts.

Aortic stent grafting is gaining acceptance rapidly as a durable and effective alternative to open surgery for abdominal aortic aneurysms (AAA). Unlike follow-up after open surgical procedures, postplacement surveillance protocols are necessary to ensure long-term freedom from device failure or aneurysm rupture. Surveillance protocols incorporating duplex scanning are effective and may reduce overall postplacement expenses. Specific device or patient anatomic features may be prone to failure, and familiarity with each approved device is a prerequisite to the performance of effective device surveillance studies. Mechanisms of failure of aneurysm exclusion after device placement, or "endoleak," have been described and categorized. Endoleak significance is directly related to location, duration, and influence on AAA diameter. Endoleak type also determines when and whether additional interventions are indicated. Future progress in endovascular AAA exclusion will depend in large part on the reliability and utility of cost-effective postprocedure surveillance protocols incorporating duplex ultrasound imaging.

Aortic Aneurysm, Abdominal↗
PubMed1991

Evaluation and treatment of erectile dysfunction following spinal cord injury: a review.

The majority of spinal cord injured (SCI) men with upper motor neuron lesions have reflex erections. However, these erections are often not adequately sustained making it difficult if not impossible to have intercourse. The majority of SCI men with lower motor neuron lesions do not have erections. Penile implants are effective in producing erections following SCI. However, they have the disadvantages of being a surgical procedure and of having the risk of infections and erosion of the implant through the skin. Intracavernous injections of papaverine and phentolamine and vacuum erection devices have recently been added to our armamentarium of ways to treat erectile dysfunction. A major concern particularly in SCI men is that papaverine and phentolamine may cause prolonged erections in SCI men. We presently have little data on the use of vacuum devices in SCI men, but preliminary reports on those who are using FDA-approved devices appear promising.

Equipment Design↗
PubMed1997

Catheter closure of secundum atrial septal defects.

Catheter occlusion of atrial septal defects has its roots in the 1950s, with early devices being implanted during closed-heart surgery without cardiopulmonary bypass. For the past 20 years, various catheter-delivered devices have undergone testing and refinement. Designs have included single- and double-disk prostheses, with a variety of materials, delivery systems, and techniques. In this monograph, the history of atrial septal defect occluders and their evaluation, results, and prognoses will be outlined. The early work of King and Mills has been advanced in the forms of the Rashkind and Lock-USCI Clamshell occluders (USCI; Billerica, Mass), the "buttoned" device (custom made by E.B. Sideris), the Babic atrial septal defect occlusion system (Osypka, GmbH; Grenzach-Wyhlen, Germany), the Das-Angel Wings atrial septal defect occlusion device (Microvena Corporation; White Bear Lake, Minn), and others. The future holds promise for approved devices in the treatment of selected secundum atrial septal defects.

Cardiac Catheterization↗
PubMed2001

Lifeline Registry: collaborative evaluation of endovascular aneurysm repair.

PURPOSE: The purpose of this study is to collect and analyze long-term outcome data on the safety and effectiveness of endovascular grafts used in abdominal aortic aneurysm repair in the United States and Canada. We aimed to help define appropriate patients for endograft therapy and to evaluate long-term device performance and patient outcome, thereby contributing to improving the care of patients with abdominal aortic aneurysms. METHODS: Data entered in the Registry include the electronic data collected under the endovascular graft manufacturers' clinical trials, prospective follow-up data of patients enrolled in these trials, both from the clinical centers and from interviews conducted at New England Research Institutes, and explant data, obtained primarily from analyses conducted by the Registry central pathology laboratory. SCOPE: The Registry records and analyzes the long-term follow-up data of patients in the clinical trials that lead to devices approved by the Food and Drug Administration. The Registry has also launched a feasibility study to expand the Registry to include patients receiving commercial endovascular grafts, the devices available following Food and Drug Administration marketing approval.

Angioplasty↗
PubMed2005

Lifeline registry of endovascular aneurysm repair: long-term primary outcome measures.

PURPOSE: To determine the long-term outcome after endovascular aneurysm repair (EVAR) of infrarenal abdominal aortic aneurysms (AAA). METHODS: Review the primary outcome measures of patients treated with endovascular grafts (EG) in the Lifeline Registry of EVAR. The registry contains data on 2,664 EG patients and 334 open surgical control (SC) patients collected under four multicenter Investigational Device Exemption (IDE) clinical trials that lead to United States Food and Drug Administration (FDA) approval with mandatory 5-year follow-up. Primary outcome measures include operative mortality, AAA-related death, all-cause mortality, aneurysm rupture, and surgical conversion. RESULTS: Pooled data from IDE clinical trials revealed that EG patients were 3 years older (73 +/- 8 years) than SC patients (70 +/- 8 years, P < .01) and had significantly more cardiac comorbidities before treatment. However, there was no difference in 30-day operative mortality between EG (1.7%) and SC (1.4%) (P = .72). Both EG and SC were successful in preventing rupture, with freedom from aneurysm rupture in 99.8% of EG and 100% of SC patients at 1 year (P = .51). Freedom from rupture remained at 99% in years 1 to 6 after EG, with no increasing risk of late rupture. There was no significant difference in the AAA-related death rate at 1 year between EG (98.2%) and SC (98.6%) (P = .64). Freedom from AAA-related death remained at 98% in years 1 to 6 after EG, with no increasing risk of late AAA-related death. Kaplan-Meier analysis at 6 years revealed freedom from aneurysm rupture in 99%, freedom from AAA-related death in 98%, and freedom from surgical conversion in 95% of EG patients. There was no difference in survival at 4 years between EG (74%) and SC (71%) (P = .49). Overall EG patient survival at 5 years was 66% and at 6 years was 52%. Women had a higher risk of rupture (2.4%) than men (1.2%) (P = .01) and a higher rate of surgical conversion (8.3%) than men (3.8%) (P < .01) but had the same low AAA-related death rate (3.5%) as men (2.1%) (P = .16) at 5 years. Most secondary interventional procedures (85%) were performed < or =30 days after EVAR. Freedom from secondary intervention was 84% at 1 year and 78% at 5 years. CONCLUSIONS: Endovascular aneurysm repair using FDA-approved devices is a safe, effective, and durable treatment for anatomically suited patients with infrarenal abdominal aortic aneurysms.

Adult↗
PubMed2003

A multicenter controlled clinical trial of open versus endovascular treatment of abdominal aortic aneurysm.

OBJECTIVE: The purpose of this study was to evaluate the safety and efficacy of a novel endovascular graft for elective treatment of infrarenal abdominal aortic aneurysm. The device is a modular bifurcated system with nitinol/expanded polytetrafluoroethylene components and a smaller profile than currently approved devices. METHODS: In a multicenter, concurrent controlled phase II trial, 334 patients underwent treatment with the Excluder bifurcated endoprosthesis (test, n = 235; W. L. Gore & Associates, Inc, Sunnyvale, Calif) or with standard open repair (control, n = 99). Preoperative characteristics, perioperative variables, follow-up clinical evaluations, and radiographic examination results through the first 2 years were analyzed with univariable and multivariable statistics. RESULTS: Patients in the test group had less blood loss (310 +/- 19 mL versus 1590 +/- 124 mL; P <.0001), fewer homologous transfusions (6% versus 32%; P <.0001), and shorter lengths of stay (2.0 +/- 0.1 days versus 9.8 +/- 1.4 days; P <.0001). Early major adverse events were markedly reduced in the test group (14% versus 57%; P <.0001), and this difference persisted at 2 years. No difference was seen in survival rate (P =.13). In the first 2 years, no deployment failure, early conversion, or aneurysm rupture occurred. At the 2-year timepoint, core laboratory read trunk migration in 1%, limb migration in 1%, limb narrowing in 1%, endoleak in 20%, and aneurysm growth in 14%. One wire discontinuity (0.6%) was identified in a discharge film. A 7% annual reintervention rate was seen in the test group in the first 2 years. SUMMARY: The test device is a safe and effective treatment compared with open surgical repair for infrarenal abdominal aortic aneurysm. The most striking benefits are reduced blood loss, fewer complications, and faster recovery. Two-year survival rate was similar.

Aged↗
PubMed2001

Distal protection devices during percutaneous coronary and carotid interventions.

Distal embolization of particulate matter complicates percutaneous coronary and peripheral interventions more often than had been recognized until recently. A number of distal protection devices are under development. The PercuSurge GuardWiretrade mark is a balloon occlusion thrombectomy device approved by the United States Food and Drug Administration for saphenous vein graft intervention. A number of filter devices utilize an expandable filter mounted on the angioplasty guidewire to facilitate entrapment of particles and safe removal. The Parodi Anti-Emboli Systemtrade mark is an example of a catheter occlusion device that establishes protection by reversing blood flow in the target vessel.

Journal Article↗
PubMed2001

Endovascular stent-grafts for the repair of infrarenal abdominal aortic aneurysms: a brief review.

In the United States nearly 1.5 million people have abdominal aortic aneurysms (AAAs). The natural history of AAAs is to enlarge and rupture. Rupture of an AAA results in an estimated 15,000 deaths per year. The major objective in the treatment of AAAs is to prevent aneurysm rupture and death. Endoluminal grafting for the treatment of aortic aneurysms is the most exciting topic in vascular surgery today. It is anticipated that approximately half of all aneurysms in the infrarenal abdominal and descending thoracic aorta will be repaired endovascularly in the future. Despite the enthusiasm for this technology, there are unanswered questions like the long-term fate of the device, management of endoleaks, and the ability to protect the patient from subsequent rupture. This article describes the two FDA approved devices in clinical use today and the indications, techniques, and potential pitfalls of endoluminal stent-grafting for the treatment of AAAs.

Aortic Aneurysm, Abdominal↗