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At least 1,423 records · Page 79Linked to original sources
PubMed2005

Humanitarian Use Devices/Humanitarian Device Exemptions in cardiovascular medicine.

The Second Dartmouth Device Development Symposium held in October 2004 brought together leaders from the medical device community, including clinical investigators, senior representatives from the US Food and Drug Administration, large and small device manufacturers, and representatives from the financial community to examine difficult issues confronting device development. The role of the Humanitarian Use Device/Humanitarian Device Exemption (HUD/HDE) pathway in the development of new cardiovascular devices was discussed in this forum. The HUD/HDE pathway was created by Congress to facilitate the availability of medical devices for "orphan" indications, ie, those affecting <4000 individuals within the United States each year. The HUD/HDE pathway streamlines the approval process and permits less well-characterized devices to enter the market. HDE approval focuses primarily on issues of safety and scientific soundness and does not require demonstration of efficacy. In the 7 years since the first device was approved in 1997, a total of 35 HDEs have been granted (23 devices, 6 diagnostic tests). As the costs to gain regulatory approval for commonly used devices increase, companies often seek alternative ways to gain market access, including the HUD/HDE pathway. For a given device, there may be multiple legitimate and distinct indications, including indications that meet the HUD criteria. Companies must choose how and when to pursue each of these indications. The consensus of symposium participants was for the HUD/HDE pathway to be reserved for true orphan indications and not be viewed strategically as part of the clinical development plan to access a large market.

Altruism↗
PubMed1998

[Predictability and precision of "target-controlled infusion" (TCI) of propofol with the "Disoprifusor TCI" system].

UNLABELLED: In Germany a TCI-system for propofol (Disoprifusor-TCI) has been commercially available since spring 1997. We investigated the prediction error and precision of this TCI system as part of a multicentre study. Bias, precision, blood concentrations and dosage of propofol were compared with patients receiving propofol via a manually controlled infusion device. METHODS: After approval by the local Ethics Committee and written informed consent, 21 patients of ASA-classification I to III scheduled for major abdominal surgery received either a target controlled infusion (group T, Disoprifusor-TCI) or a manually controlled infusion (group M) of propofol. The propofol plasma concentrations were measured by HPLC. The prediction error for each measurement, the median prediction error (MDPE) or bias, the median absolute prediction error (MDAPE) or precision and the divergence (change of the prediction error over infusion time) were calculated for both groups. RESULTS: For all patients in group T (n = 12) the bias of the TCI system was 6.7% and the precision 27.5%. For 70% of all measured plasma concentrations the absolute prediction error was < or = 37%. The divergence was -5.4% per hour. For all patients in group M (n = 9) the bias was 44.2% and the precision 50%. The mean amount of propofol infused per kilogram body weight and hour was significant higher in T (9.0 +/- 1.2 mg/kg/h) than in M (6.6 +/- 1.2 mg/kg/h, p < 0.005). CONCLUSIONS: With a precision of 27.5% the investigated TCI system (Diprifusor-TCI) showed an acceptable inaccuracy, as for TCI-systems a median prediction error of +/- 30% has to be expected due to the inherent variability of pharmacokinetic parameters. Further studies will be necessary to find out whether the investigated TCI system for propofol may offer substantial advantages.

Abdomen↗
PubMedDate not supplied

Endovascular repair of abdominal aortic aneurysms using the EGS tube and bifurcated graft systems.

Left untreated, aneurysmal disease of the abdominal aorta is a highly lethal condition. Standard transabdominal repair of aortic aneurysm, although successful and durable, continues to be plagued by significant morbidity, mortality, and cost. Placement of an endovascular graft through a femoral arteriotomy is a new technique that could potentially reduced this morbidity and cost without sacrificing efficacy. This report details the development of a U.S. Food and Drug Administration (FDA)-approved endovascular grafting device. In addition, we describe our experience screening patients and summarize our clinical experience with the placement of both tube and bifurcated endovascular graft systems. To date, 16 patients have undergone endovascular repair with a tube graft at UCLA, and three bifurcated grafts have been placed. Two patients required conversion to conventional open aneurysm repair. All the remaining procedures were successful, and there were no perioperative deaths or major complications. We conclude that endovascular grafting of aortic aneurysms is both feasible and safe. Long-term patency and the ability of this technique to prevent the known complications of aortic aneurysmal disease remain unanswered questions at this time.

Angioplasty, Balloon↗
PubMed2002

Aneurysm morphology as a predictor of endoleak following endovascular aortic aneurysm repair: do smaller aneurysm have better outcomes?

Since the Food and Drug Administrations' approval of endovascular devices for abdominal aortic aneurysm (AAA) repair, clinicians have been relaxing the strict inclusion criteria present during the clinical trials. Although the long-term natural history of endoleaks remains unclear, attachment site leaks (type I) are believed to represent an ongoing risk for future rupture. We reviewed our experience with endovascular AAA repair to elucidate factors that predispose toward the development of endoleaks and found that larger AAAs are significantly more likely to have a short proximal neck and severe proximal angulation. These factors likely contribute to the significantly increased rate of type I endoleaks that occurred after endovascular repair of large AAAs. Small AAAs (<5) had the lowest rate of endoleaks overall (8.3%) and of type I endoleaks in particular (0%). We conclude that AAA size and morphology can be used to predict which aneurysms will experience attachment site endoleaks in their course; AAAs from 4.5 to 5 cm in diameter may be particularly well suited for endovascular repair in this regard.

Aged↗
PubMed2007

Wireless capsule endoscopy: from diagnostic devices to multipurpose robotic systems.

In the recent past, the introduction of miniaturised image sensors with low power consumption, based on complementary metal oxide semiconductor (CMOS) technology, has allowed the realisation of an ingestible wireless capsule for the visualisation of the small intestine mucosa. The device has received approval from Food and Drug Administration and has gained momentum since it has been more successful than traditional techniques in the diagnosis of small intestine disorders. In 2004 an esophagus specific capsule was launched, while a solution for colon is still under development. However, present solutions suffer from several limitations: they move passively by exploiting peristalsis, are not able to stop intentionally for a prolonged diagnosis, they receive power from an internal battery with short length, and their usage is restricted to one organ, either small bowel or esophagus. However the steady progresses in many branches of engineering, including microelectromechanical systems (MEMS), are envisaged to affect the performances of capsular endoscopy. The near future foreshadows capsules able to pass actively through the whole gastrointestinal tract, to retrieve views from all organs and to perform drug delivery and tissue sampling. In the long term, the advent of robotics could lead to autonomous medical platforms, equipped with the most advanced solutions in terms of MEMS for therapy and diagnosis of the digestive tract. In this review, we discuss the state of the art of wireless capsule endoscopy (WCE): after a description on the current status, we present the most promising solutions.

Capsule Endoscopes↗
PubMed2003

Endoscopic therapy for gastroesophageal reflux disease.

Many new and developing endoscopic techniques for treatment of gastroesophageal reflux disease (GERD) are now or will soon be available for clinical use. These new therapies are directed to the gastroesophageal junction and include three basic techniques, which are outlined in this review: thermal remodeling and neurolysis of the lower esophageal sphincter (LES) zone; bulking or reinforcing of the LES; and plicating gastric folds at the gastric cardia. Only two of these treatments, radiofrequency ablation and fundic fold plication, have been approved by the US Food and Drug Administration (FDA). Published clinical research on endoscopic treatment is reviewed, although it is mostly comprised of open-label trials and anecdotal clinical reports. Complications of endoscopic GERD treatments are described as well as real and potential pitfalls of these techniques. Problems caused by premature introduction of endoscopic GERD treatments into the marketplace are also discussed, along with the rationale for FDA approval of similar devices.

Catheter Ablation↗
PubMed1993

Transesophageal atrial pacing for intraoperative sinus bradycardia or AV junctional rhythm: feasibility as prophylaxis in 200 anesthetized adults and hemodynamic effects of treatment.

Sinus bradycardia (SB) or atrioventricular junctional rhythm (AVJR) may produce circulatory insufficiency in anesthetized surgical patients, especially those with cardiovascular disease. Chronotropic drugs have been the preferred initial treatment, except when epicardial pacing is available. Alternative methods include transvenous or transcutaneous pacing. Drugs may be ineffective or have undesirable effects. Transvenous pacing is time consuming and risky, and transcutaneous pacing is not universally applicable or effective. Transesophageal atrial pacing (TAP) lacks these disadvantages, but unavailability of equipment and unfamiliarity with the method has discouraged widespread use. Feasibility of TAP as prophylaxis for intraoperative SB or AVJR was tested with approved or investigational devices in 200 anesthetized surgical patients, not necessarily with cardiovascular disease or having cardiac surgery. Of these, 84 later had incidental SB < or = 60 beats/min, and 23 of these 84 had SB < or = 50 beats/min. Thirteen patients had AVJR (72 +/- 4 beats/min; mean +/- SEM). TAP at 80 beats/min for SB, or at a rate sufficient to overdrive AVJR, was effective initial treatment in all patients.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed2004

Utility of the Safe-Cross-guided radiofrequency total occlusion crossing system in chronic coronary total occlusions (results from the Guided Radio Frequency Energy Ablation of Total Occlusions Registry Study).

The Safe-Cross radiofrequency guidewire (IntraLuminal Therapeutics, Carlsbad, California) combines 3 capabilities: (1) steerability of a conventional 0.014-in intermediate-stiffness guidewire, (2) optical coherence reflectometry to warn the operator when the wire tip approaches within 1 mm of the vessel wall, and (3) delivery of radiofrequency energy pulses to the wire tip to facilitate passage through an occluded segment. The Guided Radio Frequency Energy Ablation of Total Occlusions Registry was a prospective, nonrandomized, multicenter registry that enrolled 116 patients who had long-term coronary total occlusions and in whom a >10-minute good-faith attempt to cross the occlusion using conventional guidewires had failed. The median known duration of occlusion was 22 months (32%; >1 year), and the median length of the occluded segment was 25 mm (25%; >30 mm). Device success was achieved in 63 of 116 of patients (54.3%), and major adverse events occurred in 6.9%, consisting predominantly of isolated increases in cardiac enzymes with no procedure-related deaths, Q-wave myocardial infarctions, or emergency bypass operations. Clinical perforation occurred in 2.6% of patients; of these, perforation in only 1 patient (0.9%) was adjudicated to be directly related to the Safe-Cross radiofrequency wire rather than to the stiff and/or hydrophilic wires used after an inability to advance with the Safe-Cross. Based on these data, the device has been approved in Europe and was recently (January 2004) granted 510K clearance by the Food and Drug Administration.

Adult↗
PubMed2005

Direct and indirect comparison meta-analysis demonstrates the superiority of sirolimus- versus paclitaxel-eluting stents across 5854 patients.

There is ongoing debate to identify the most effective, safe and cost-beneficial drug-eluting stent, between the two currently approved and used devices, i.e. sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES). To date, head-to-head comparison studies of SES vs PES have been however limited by relatively small sample sizes and the low number of events typically associated with these highly effective coronary devices. To overcome the drawbacks of single trials, direct and indirect comparison meta-analyses have been designed and conducted to thoroughly compare sirolimus- vs paclitaxel eluting-stents. This article provides results of a pooled analysis of such indirect and direct comparisons, definitively demonstrating across 5854 patients the superiority of SES in comparison to PES (odds ratio 0.62 [95% confidence interval 0.50-0.75], p<0.0001 for binary angiographic restenosis, and odds ratio 0.66 [0.52-0.84], p=0.0008 for target lesion revascularization). Indeed, such combination of direct and indirect comparisons should also be envisaged to soundly and timely appraise the next generation of drug-eluting stents.

Angioplasty, Balloon, Coronary↗
PubMed2004

Overt ischemic colitis after endovascular repair of aortoiliac aneurysms.

OBJECTIVE: Controversy exists as to the cause of ischemic colitis complicating endovascular aneurysm repair. Occlusion of the hypogastric arteries (HAs) during endovascular repair of aortoiliac aneurysms (AIAs) results in a significant incidence of buttock claudication, and has been suggested as a causative factor in the development of postprocedural colonic ischemia, in addition to factors such as systemic hypotension, embolization of atheromatous debris, and interruption of inferior mesenteric artery inflow. To analyze the relationship between perioperative HA occlusion and postoperative ischemic colitis, we reviewed our experience over 2 years with Food and Drug Administration-approved endovascular graft devices for treatment of AIAs. METHODS: Elective repair of AIAs with bifurcated endovascular grafts was performed in 233 patients over a 2-year period. These included 184 AneuRx grafts, 17 Ancure grafts, and 32 Excluder grafts. During the experience, 44 patients (18.9%) underwent unilateral perioperative HA occlusion (28 right, 16 left) during the course of endovascular AIA repair, and 1 patient (0.4%) underwent bilateral HA occlusion. RESULTS: In 4 patients (1.7%) signs and symptoms of ischemic colitis developed 2.0 +/- 1.4 days postoperatively. In all patients the diagnosis was confirmed at sigmoidoscopy, and initial treatment included bowel rest, hydration, and intravenous antibiotic agents. Three patients with bilateral patent HAs required colonic resection 14.7 +/- 9.7 days after the initial diagnosis, and 2 of these 3 patients died in the postoperative period. Pathologic findings confirmed the presence of atheroemboli in the colonic vasculature in all 3 patients who underwent colonic resection. The fourth patient had undergone multiple manipulations of the left HA in an unsuccessful attempt to preserve patency of this vessel during AIA repair. This patient recovered completely with nonoperative management. Perioperative unilateral HA occlusion was not associated with a significantly higher incidence of postoperative ischemic colitis. CONCLUSION: Perioperative HA occlusion during aortoiliac open or endovascular surgery may contribute to development of the rare but potentially lethal complication of ischemic colitis. However, our extensive experience suggests that embolization of atheromatous debris to the HA tissue beds during endovascular manipulations, rather than proximal HA occlusion, is the primary cause of clinically significant ischemic colitis after endovascular aneurysm repair.

Aged↗
PubMed2004

A preliminary report on the biocompatibility of photopolymerizable semi-interpenetrating anhydride networks.

A new family of poly(anhydrides) (PA) has been developed which can be cured photochemically to produce degradable networks. These degradable anhydride networks may be useful in orthopaedics as bone cements and as matrices for drug delivery. This system, which is a semi-interpenetrating network (semi-IPN), has been evaluated for biocompatibility in subcutaneous tissue in rats and appears to undergo degradation primarily by surface erosion. The inflammatory response to the semi-IPN implants was minimal at both short (3 and 6 weeks) and long (28 weeks) time points and the fibrotic response was largely absent throughout the duration of this study. Furthermore, the OrthoCure implant material integrated well with the surrounding tissue and was invaded with vascularized connective tissue. For reference, linear PA controls were tested and showed a foreign body response culminating in the formation of relatively avascular fibrous capsule several cell layers thick, which became thicker over time, a response similar to what is typically observed in FDA approved implantable polymeric device systems.

Absorbable Implants↗
PubMed2003

Extracorporeal shock wave therapy for plantar fasciitis.

Shock wave therapy is quickly becoming a mainstay treatment for chronic recalcitrant plantar fasciitis, and many more applications for this therapy may exist. Many advances have been made in regard to this modality of treatment in just a few decades since it was first investigated in the 1950s. Much research has been conducted, revealing the physics and physiologic effect of shock wave therapy. Devices are now approved that produce shock waves for medicinal purposes by one of the three primary methods of shock wave generation. Studies and research are actively being reported and published that demonstrate shock wave therapy success rates comparable to those found in surgical intervention but without the risks inherent in surgery. In conclusion, ESWT has proved to be a viable treatment option for the intervention of chronic recalcitrant plantar fasciitis.

Chronic Disease↗
PubMed2003

Future therapies for heart failure.

The treatment of heart failure has changed as the understanding of the disease evolves. Heart failure remains the only cardiovascular disease that continues to rise in both incidence and prevalence, despite recent advances in treating symptoms and thwarting disease progression. Many opportunities exist for improving patient outcomes with pharmaceutical agents and technologies available now or in the near future. This article discusses recently approved drugs and devices and clinical trials that may affect the management of this challenging disease.

Cardiac Pacing, Artificial↗
PubMed2000

Assessment of a polyester-covered nitinol stent in an atherosclerotic swine model.

PURPOSE: To evaluate the short-term patency and healing characteristics of the Cragg EndoPro covered stent in an atherosclerotic model as one of the Food and Drug Administration requirements before possible approval of the device for human use in the United States. MATERIALS AND METHODS: Seventeen self-expanding stent-grafts were placed in the aorta and right and left iliac arteries of six Yucatan microswine exposed to a regimen of accelerated atherosclerosis. The stent-grafts were constructed from nitinol wire formed into a tubular zigzag configuration. The stent frame was covered by a thin woven polyester fabric tube, with medium permeability, available in multiple diameters and lengths. The animals were killed at 24 hours, 3 months, and 6 months. Assessment was done by angiography and histology. RESULTS: All stents were patent immediately after deployment. Two stents were occluded at follow-up, indicating an 88% patency rate. Minor lumen narrowing was found at the follow-up intervals. Histologic examination revealed a mixture of mature and immature endothelial cells lining both the native and stented regions in all vessels examined. The new endoluminal surface was composed primarily of fibrocollagen and elastic fibers and smooth muscle cells. Intimal thickness was inversely correlated to medial thickness. Medial compression with atrophy was observed routinely with rare necrosis. Complete tissue ingrowth was seen by 3 months. The degree of vascular inflammation increased over time, as well as the foreign body giant cell reaction to the polyester fabric. CONCLUSION: The patency rate does not appear to be better than that with angioplasty or noncovered stent placement in the studied time frame. The progressive vascular inflammatory changes noted should be further investigated in longer-term animal trials to ensure its safety in humans because this device is meant to be permanent.

Alloys↗
PubMed2001

Diagnosis and management of type 2 endoleaks after endovascular aneurysm repair.

Endovascular repair is a major treatment advance in patients with large infrarenal abdominal aortic aneurysms. Since the FDA approved two commercial devices 2.5 years ago, over 40,000 patients have undergone this procedure in the United States. Although we have learned a great deal, more than a few mysteries relating to the long-term performance of these devices remain. This results in never-ending surveillance protocols searching for graft failure and aneurysm expansion. One of the especially contentious issues is the management of type 2 endoleaks. Unlike other endoleaks that are related to problems with the graft and/or fixation, this type of leak occurs in patients with properly functioning devices. This is why so much controversy exists about whether or not these patients must be treated. Some advocate "watchful-waiting" intervention only when there is aneurysm expansion. Others routinely treat patients with type 2 endoleaks in an attempt to prevent expansion. As with most controversial topics, if you look carefully, there is more agreement than disagreement between the two groups. In this review, we will first describe the methods used for endoleak diagnosis and treatment. We will then review our current endoleak treatment algorithm and explain its rationale for use.

Algorithms↗
PubMed2001

Development of functional electrical stimulators utilizing cochlear implant technology.

In 1983, R. Davis proposed the development of a functional electrical stimulator, based on multi-channel cochlear implant technology, for the restoration of function in spinal cord injured paraplegic subjects. In 1984, the US Veteran Administration funded the initial investigations including animal experiments and purchase of a FES stimulator based on the Nucleus 22 cochlear implant. In 1987, the US Food and Drug Administration approved an Investigational Device Exemption (IDE# G870142) for this FES project. In 1991, the first stimulator was implanted in a 21-year old male paraplegic subject (complete thoracic spinal cord lesion at level #10), who was subsequently able to stand and to perform one-handed tasks for up to 1h. In 1996-1997 development started on a new multi-function FES system. In 1998, a stimulator was implanted in a 35-year-old male paraplegic subject (complete thoracic spinal cord lesion at level #10). After 8 months of use providing multiple functions including bladder voiding, the implant's internal antenna wire broke. A modified implant (FES 24-B) is due to be implanted in July 2001.

Adult↗
PubMed2003

Peptide based adsorbers for therapeutic immunoadsorption.

Peptides as ligands for immunoadsorption exhibit several potential advantages over native proteins. Two newly developed adsorbers are based on peptides covalently coupled to sepharose CL-4B. Globaffin is capable of binding immunoglobulins independent from their antigen specificity and thus, applicable in transplant recipients and several antibody mediated autoimmune diseases. Among others, the most important disorders suitable for the treatment with Globaffin are rheumatoid arthritis, systemic lupus erythematosus, and acute renal transplant rejection. Coraffin is a specific adsorber using two linear peptide ligands mimicking epitopes of the beta1-adrenergic receptor, that bind corresponding autoantibodies from patients suffering from idiopathic dilated cardiomyopathy. Specific immunoadsorption has been shown to be beneficial for patients with dilated cardiomyopathy. Coraffin can be used as a new therapeutic option for these patients, who get only limited benefit from medical therapy. Both adsorbers may be combined with all approved apheresis control devices available.

Autoantibodies↗
PubMed2004

Endoluminal therapies for gastroesophageal reflux disease.

While medical therapy, particularly with proton pump inhibitors, is effective for the large majority of patients with reflux disease, there remains a subset of patients who are dissatisfied, due to cost, side effects of medications, or persistent symptoms such as regurgitation. For this population, surgical fundoplication has been, and remains, an appropriate option. A new class of endoluminal interventions, attempting to create a mechanical antireflux barrier, has emerged recently. Three such devices are currently approved and available, and a number of others are in various stages of evaluation. This article will review the approved technologies, as well as selected promising emerging ones. with particular emphasis on the scientific evidence available to date supporting their efficacy.

Biocompatible Materials↗