NeoGuide Systems (Los Gatos, California), a developer of technology to prevent and treat colorectal cancer, reported receiving FDA 510(k) clearance to market its NeoGuide Endoscopy System. The system is designed to enhance physician control of the colonoscope and to eliminate looping, the principal reason why conventional colonoscopy procedures are painful, time consuming, and difficult.
“The company was founded in 2000, and it’s taken awhile for us to get to this point, so it’s a big milestone for us,” Robert Eno, vice president of marketing for NeoGuide, told Biomedical Business & Technology.
Amir Belson, MD, co-founder and president of NeoGuide, said in a prepared statement: “It is the result of years of research and development by an extremely dedicated team. We look forward to working with gastroenterologists to greatly improve their ability to screen, treat and diagnose colorectal cancer.”
Eno said the company is “very careful” in describing the product, since the 510(k) indicates “substantial equivalence” to existing products.
However, he explained that looping is fundamental to traditional colonoscopy. “It’s inherent in the way the current devices work in that you’re able to steer the tip but the shaft of the [device] is uncontrolled,” Eno said.
He said that it’s a difficult procedure because a physician is essentially inserting a “flexible tube inside another flexible tube, since the colon is “free-floating in the abdomen.”
Eno said, “The only way that they can advance the scope is actually stretching the colon until there is counter-force against the wall and [it] stretches the surrounding tissue,” adding that this is what leads to the pain in the procedure and the difficulty for the physician.
The NeoGuide Endoscopy System is designed to provide control for the physician over the shaft of the device that is inserted into the colon, in the expectation that it will reduce pain and potentially reduce the amount of sedation needed.
Unlike conventional scopes, the NeoGuide colonoscope is built out of multiple segments that can be actively controlled. As the physician inserts the NeoGuide scope, the system automatically creates a 3-D map of the colon and then directs these segments to follow the path taken by the tip.
The company will be gathering additional data on the device during 2006 and developing iterations of the device in preparation for an early 2007 launch. NeoGuide, a venture-backed company with about 34 employees, will manufacture the device and will be building up its sales force in the meantime.
Elsewhere in the product pipeline:
• Accuray (Sunnyvale, California), manufacturer of the CyberKnife Robotic Radiosurgery System, said that more than 300 surgeons, radiation oncologists and medical physicists gathered last month for the 5th annual CyberKnife Society Users’ Meeting to discuss the latest in robotic radiosurgery applications using the CyberKnife system. A significant part of the meeting focused on clinical applications using the CyberKnife’s ability to treat tumors anywhere in the body. Several clinical presentations reported on the success of radiosurgical treatments of lung lesions with a focus on patients with otherwise limited treatment options. Physicians attributed the recent foray into thoracic and general surgery cases in large part to the Synchrony Respiratory Tracking System, a key feature of the CyberKnife system. Synchrony technology allows patients to breathe normally throughout their treatment without breath-holding or gating techniques thus enabling clinicians to image, track and treat complex targets, while minimizing damage to healthy tissue or critical structures.
• Acusphere (Watertown, Massachusetts) said that the Journal of Controlled Release recently published a research paper describing the company’s porous microparticle technology and AI-700, an ultrasound contrast agent for use in echocardiography. AI-700 is Acusphere’s lead product candidate and is currently in Phase III clinical trials. The cardiovascular drug is intended to improve the use of ultrasound in effectively screening patients for coronary heart disease (CHD) by enabling clinicians to obtain information regarding myocardial perfusion with ultrasound, which the company said has potentially significant cost and convenience advantages over nuclear stress tests. In Phase II clinical trials, ultrasound using AI-700 demonstrated greater than 30% higher sensitivity than ultrasound without AI-700 and equal sensitivity in detecting CHD to nuclear stress tests.
• AGA Medical (Golden Valley, California) has joined the growing ranks of companies evaluating the benefit of patent foramen ovale (PFO) closure for the treatment of migraine, saying it has received conditional approval from the FDA to initiate a new study under an existing investigational device exemption to examine the possible connections between migraines and PFOs. PFOs, heart defects found in more than 20% of all adults, are small flap-like openings between the upper chambers of the heart. These openings are normal in fetuses but usually close shortly after birth. When it remains open, or patent, the PFO allows blood to bypass the filtering system of the lungs. While the actual mechanism of action is still unclear, it is theorized that substances such as very small blood clots or chemicals in this unfiltered, nonregenerated blood traveling directly to the brain may trigger migraine attacks. The Prospective Randomized investigation to Evaluate the incidence of headache reduction in subjects with Migraine and PFO Using the Amplatzer PFO Occluder compared to Medical Management (PREMIUM) trial is a prospective, randomized, two-arm, double-blind, multi-center trial in the U.S. to determine whether patients who undergo closure of a PFO with an Amplatzer device have a reduction in both the frequency and severity of migraine headaches. AGA Medical said the study is expected to enroll about 400 patients at up to 30 medical centers. The study will evaluate patients with refractory migraine with and without aura (visual disturbance), randomized on a 1-to-1 basis to receive either an Amplatzer-driven treatment or standard of care medical management.
• Agilent Technologies (Palo Alto, California) reported the introduction of the Agilent 1200 Series LC (liquid chromatography) system, replacing the 1100 Series LC. With more than 60 instrument modules, the Agilent 1200 can be configured for all major LC applications, including a new rapid-resolution format. HPLC-Chips, which can provide customers with more than a 1,000-fold improvement in sensitivity over conventional LC/MS, are available to apply this technology for both small and large molecule work. The 1200 Series Rapid Resolution System provides up to 20 times faster analysis and 60% higher resolution than conventional LC, yet can still run any traditional LC method. A special high-throughput configuration of the 1200 Rapid Resolution system allows sequential execution of more than 2,000 samples per day on a single system. The system features more than 70 new Rapid Resolution High Throughput columns, which range in size and come in more than six bonded phases. The system includes a new high-performance pump that can handle flow rates from 0.05-5 ml/min and up to 600 bar pressure, and features a new high-performance degasser, autosampler, column compartment and UV and MS detectors. The system can be optimized for highest speed and resolution in both LC/UV and LC/MS applications.
• Analogic (Peabody, Massachusetts) reported that the FDA has given market clearance for the FetalGard Lite-NIBP (Non-Invasive Blood Pressure) fetal monitor. The FetalGard Lite-NIBP measures maternal non-invasive blood pressure for monitoring pregnancy-induced hypertension in addition to providing standard fetal monitoring capabilities. The device offers “beat-to-beat” fetal heart rate analysis on twins, and measures maternal uterine activity and blood pressure. It is portable, battery-operated, and weighs five pounds, making it appropriate for use in a variety of settings. The company said the FetalGard Lite-NIBP also offers the first alternative to Z-fold paper because it can store and transfer tracings to a PC for viewing, reporting and printing. Alternatively, multiple patients’ records can be stored and subsequently “fast printed” to an Analogic Z-fold recorder when hard copies are needed for review or patient records.
• Boston Scientific (Natick, Massachusetts) reported the results of a five-year retrospective study on Peripherally Inserted Central Catheters (PICCs) with Pressure Activated Safety Valve (PASV) Technology, indicating a significant reduction in rates of both occlusion and infection. The study, conducted by Vanderbilt University Medical Center (VUMC; Nashville, Tennessee), was presented at the recent Association for Vascular Access conference. The study collected data over a five-year period on more than 12,500 PICC procedures performed by trained personnel in the medical center’s specialized PICC nursing program. The retrospective analysis revealed an increasing rate of successful placements since the inception of VUMC’s PICC Service program in 2000. The choice of PICC technology had a significant impact on the likelihood for catheter occlusion and infection, both complications that can result from PICC procedures. Specifically, patient outcomes demonstrated statistically significant lower rates of occlusion, infection, or both when the PICCs with PASV Valve technology were used. The chance for occlusion was 4.81 times lower, while infection was 1.35 times lower. Overall, the chance for either occlusion or infection was 2.24 times lower when patients received a PICC with PASV Valve technology.
• Collagen Matrix (Franklin Lakes, New Jersey) said it has received FDA 510(k) clearance of its Collagen-Mineral Composite Bone Graft Material for use in orthopedic-spine applications involving bone repair. The Collagen-Mineral Composite Bone Graft Material, combined with autologous bone marrow, is used to fill bony voids or gaps of the skeletal system, including spine, extremities and pelvis. The product is a composite matrix available in strips, pads, or granular form for surgical implantation. Its primary components are type I collagen and anorganic bone mineral. The natural anorganic bone mineral is derived from bovine cancellous and cortical bone and, according to the company, is physically and chemically comparable to the mineralized matrix of human bone. The mineral particles are dispersed within highly purified type I collagen fibers, forming a 3-D open porous matrix for use as an osteoconductive material. The addition of autologous bone marrow further enhances the bone forming capability of the product from bone inductive factors and bone forming cells in the bone marrow. The Collagen-Mineral Composite is provided as a sterile, dry material that is hydrated with autologous bone marrow at the point of use.
• Cordis (Miami Lakes, Florida), a Johnson & Johnson company, reported that the Cypher Sirolimus-Eluting Coronary Stent may reduce restenosis and the occurrence of major adverse cardiac events in patients with complex coronary artery lesions without increasing the risk of thrombosis, according to a study published in the Jan. 17 issue of the Journal of the American College of Cardiology. The SCANDSTENT (Stenting of Coronary Arteries in Non-Stress/Benestent Disease) study is the only randomized study examining the Cypher stent against bare-metal stents that includes complex patients, defined as patients with blockages longer than 15 mm, side-branch lesions, ostial lesions, and angulated lesions. Investigators found that at six months the Cypher stent outperformed the bare metal stent. When comparing the Cypher stent group with the bare metal stent group, researchers found improvements in the narrowest vessel size, significant reductions in narrowing of the vessel, a dramatic reduction in narrowing of the vessel on multiple occasions and significantly lower rates of target lesion revascularization.
• CryoLife (Kennesaw, Georgia), a biomaterials and biosurgical device company, reported that it has received approval from the FDA for two new spreader tips for its BioGlue Syringe applicators. The 12 mm and 16 mm fan-like extensions deliver a thinner, wider band of BioGlue Surgical Adhesive designed to more quickly seal suture lines. The new tips fit all sizes of the self-contained, disposable syringes, which are now available in 2 ml, 5 ml and 10 ml volumes. In addition, the tip collars are colored green so they are readily identified in the operating suite as part of the BioGlue Syringe system. BioGlue is a two-component adhesive that creates a flexible, mechanical seal, independent of the body’s clotting mechanism, within 20 to 30 seconds and reaches its maximum bonding strength in two to three minutes.
• GeneFluidics (Monterey Park, California) said research reported in the February Journal of Clinical Microbiology investigated its biosensor technology in the diagnosis of urinary tract infections (UTI) – the second-most-common bacterial infection – in a clinically relevant timeframe. Researchers used GeneFluidics’ biosensor, coated with species-specific genetic probes designed at University of California, Los Angeles, to correctly identify the infection-causing gram-negative bacteria species in 98% of the tested clinical UTI urine samples. These results represent the first ever species-specific detection of bacteria in human clinical fluid samples using a microfabricated electrochemical sensor array, the company said. The test provided results in 45 minutes, compared to two days with conventional methods. GeneFluidics said it anticipates the rapid test may be available in the next two to three years.
• Hill-Rom (Batesville, Indiana) reported the availability of a new medical “arm” system. The Latitude arm system serves as a mobile headwall, allowing caregivers to position and configure it in the best way necessary to deliver medical gasses, electric power and other critical services to treat patients. The Latitude system eliminates bed positioning; the arm and services can be moved to the patient. When a patient must be treated or transferred, the arm moves out of the way, providing better access for caregivers and equipment. When not in use, the arm system can be “docked” flat against the wall to save space. The Latitude also features a locking system that prevents drift; increased spacing between outlets, making it easier to use; improved patient environments; and provision of space above the patient for lighting, lifts and other equipment.
• HydroCision (Billerica, Massachusetts) said that a multi-center study demonstrated that the company’s fluidjet-based instruments removed nearly 96% more soft tissue from the difficult-to-access posterior contralateral region than conventional surgical instruments in preparation for spinal fusion. HydroCision’s HydroSurgery system, including SpineJet XL instruments, uses a high-velocity stream of water to simultaneously cut and aspirate damaged tissue from spinal discs in preparation for fusion. The technique’s advantages, illustrated by the study conducted on cadaver models, include the safe and more effective removal of degenerated disc-nucleus material and endplate preparation that can lead to optimal clinical outcomes.
• LDR Spine (Austin, Texas) has obtained approval for an investigational device exemption (IDE) from the FDA that will allow it to conduct a pivotal human clinical trial to investigate the safety and effectiveness of the Mobi-C cervical artificial disc. According to the company, this will be the only active one- and two-level clinical trial approved by the FDA for an artificial cervical (neck) disc and the first FDA-approved study of a second-generation cervical disc device. The Mobi-C is commonly used to treat degenerative disc disease in the cervical spine. Its purpose is to restore normal biomechanical function after disc excision, provide pain relief, and at the same time avoid subsequent degeneration at adjacent levels. The product is currently available in 20 countries throughout Europe and Asia. The Texas Back Institute (Dallas), the largest freestanding spine specialty clinic in the U.S., will be the lead clinical site in the investigational study. “The difference between preserving motion and fusing is quite radical,” said Steve Whitlock president and CEO of LDR Spine. “Basically,” he told BB&T, with his company’s system “you allow the patient after the procedure to retain motion in their disc. What that does for them is it helps to theoretically preserve the adjacent levels [of the cervical spine].” The study will follow patients for two years. It will include up to 20 medical centers throughout the U.S. Whitlock said the trial could enroll up to about 600 patients, with a roughly 50/50 spilt between the one- and two-level fusion arms of the study. The control arm for the study will be an anterior cervical discectomy and fusion, the current standard of care for cervical disc repair.
• A potentially revolutionary new feature may soon be added to Medtronic’s (Minneapolis) cardiac resynchronization therapy defibrillator (CRT-D) line if a new trial being conducted in the U.S. and other sites around the world proves successful. The company reported the first implants in the U.S. of its Concerto CRT-D with atrial therapies (AT). The clinical study, dubbed Concerto-AT, is a prospective, non-randomized, multi-center, global clinical trial involving up to 425 patients at up to 50 sites in Europe, the U.S and Japan. The purpose of the study is to assess the safety and efficacy of atrial defibrillation therapy in patients with a current indication for CRT and ICD. The Concerto/Virtuoso line of implantable devices, which includes the Concerto CRT-D and Virtuoso implantable cardioverter-defibrillator (ICD), will be Medtronic’s first cardiac rhythm management products with Conexus Wireless Telemetry. Conexus, which utilizes the medical implant communication service (MICS) radio frequency band, 402-405 MHz, is designed to enable communication between a patient’s implanted device and home monitor or clinician programmer at a range of six feet to 16 feet. According to George Crossley, MD, chief of electrophysiology at Baptist Hospital (Nashville, Tennessee), whose hospital is involved in the trial, the Conexus telemetry will enhance efficiencies at device implant and during in-office follow-up visits, as well as enable automatic, wireless data transmission from the patient’s device to a home monitor. “The biggest advantage [of the Concerto CRT-D], other than just convenience for us, is when we start using remote telemetry at home,” he told BB&T, adding that the device “has an enormous amount of diagnostic capability.”
• Miracle-Ear (Minneapolis), a hearing healthcare provider and division of Amplifon USA, said its family of Open Fit digital hearing aids is available immediately at Miracle-Ear locations nationwide. The company said the new line of hearing aids delivers more natural sound clarity because the ergonomic design uses ultra-thin, virtually invisible tubing and comfortable, soft tips to eliminate the “plugged up” muffled sound in the ear canal. The Open Fit design provides increased comfort and cosmetic appeal because the tiny, lightweight receiver tucks neatly behind the ear. The Open Fit hearing aids also allow one-visit fitting that requires no ear molds.
• Philips Medical Systems (Andover, Massachusetts) reported its new line of obstetrical care fetal and maternal monitors, Avalon FM20 antepartum and Avalon FM30 intrapartum. Built on Philips’ IntelliVue patient monitoring platform, the Avalon fetal monitors feature enhanced functionality and documentation capabilities in a compact, ergonomic, and easy-to-use product. Both monitors can be used to monitor multiple births, with advanced features that include high-quality ultrasound tracing and cross channel verification. The Avalon FM20 and FM30 monitors integrate monitoring of maternal blood pressure and pulse rate with measurement of multiple fetal heart rates and uterine activity. The Avalon FM30 covers patients from the onset of contractions through the final stages of delivery with its full set of external and internal fetal parameters and maternal monitoring capabilities. Data from the monitors can be automatically transmitted to the Philips OB TraceVue obstetrical information system for comprehensive information management across the obstetrical care continuum. Philips also reported the availability of its new fetal monitoring starter kits – packages of companion supplies for the Avalon FM20 and Avalon FM30.
• Procter & Gamble (Cincinnati) sponsored a study at the Cincinnati Children’s Hospital Medical Center that shows that its ThermaCare Heatwraps are safe and effective for treating catheter thrombo-phlebitis, a painful and potentially dangerous vein inflammation that may occur after intravenous cath-eter placement in children. The results were presented this month at the annual meeting of the Society of Critical Care Medicine in San Francisco. Children in the study were treated with ThermaCare Heatwraps, which provide continuous, low-level heat over an eight-hour period, for eight hours each day from one to three days. Complete and rapid resolution of symptoms occurred in 90% of patients with no complications, the study authors reported.
• Scandius BioMedical (Littleton, Massachusetts) said that its TriTis Tibial Fixation System has been granted FDA 510(k) market clearance and has been used successfully in anterior cruciate ligament (ACL) reconstruction, the largest sports-related orthopedic joint injury. The company said the TriTis Tibial Fixation System's design provides strength in three ways: a cleat for tissue compression in the tunnel, an off-axis fixation screw to anchor the device and a fixation washer to capture graft limbs preventing graft slippage. When used in conjunction with the Stratis ST Femoral Fixation, Scandius said it is able to provide orthopedic surgeons with a complete solution for reconstruction of the ACL.
• SenoRx (Aliso Viejo, California) said that more than 30 healthcare institutions are now capable of performing MRI-guided biopsy procedures using its EnCor Multi-Modality, Modular Biopsy System. EnCor is the first fully programmable, automated, multi-modality, modular breast biopsy system available representing the next generation of technology in breast disease diagnosis. Additionally, SenoRx has three new 510(k)-cleared products scheduled to launch in the next 18 to 24 months.
• Siemens Medical Solutions (Malvern, Pennsylvania) reported the general availability of Soarian Community Access, an information technology solution that enables healthcare providers to securely connect with patients and other members of the healthcare community online. The latest addition to the Soarian family, the Web-native solution provides secure, single sign-on access to browser and non-browser-based applications, web content, online services and content created by a health enterprise. It also features a web-based messaging system for secure communications and information exchange between hospitals, physician providers, ancillary providers and patients. The solution is currently live at St. Luke’s Health System (Boise, Idaho), a 369-bed tertiary care, and Northwest Physicians Network (Tacoma, Washington), a 424-member independent physician association.
• Signalife (Greenville, South Carolina), focused on the detection of cardiovascular disease through continuous ECG signal monitoring, reported that Duke University (Durham, North Carolina) has completed the Device Implementation, Validation and Application Program for the company’s initial product, the Fidelity 100 Ambulatory EKG/ECG Monitor. A total of 108 patients, with clinical indications for elective or possible percutaneous coronary intervention, were recorded to provide detailed documentation of the device’s ability to detect and quantify transient ischemic episodes in comparison to conventional ECG devices. Data is being analyzed by the eECG Core Laboratory at the Duke Clinical Research Institute.
• Sontra Medical (Franklin, Massachusetts) said it has introduced its Generation 1.75 SonoPrep skin permeation device for topical lidocaine delivery. The upgraded device has a new and improved ultrasonic hand piece and fluid delivery system that is smaller, simpler and less expensive to manufacture. The new hand piece also will be incorporated into the second-generation SonoPrep skin permeation device scheduled to be introduced in May. The SonoPrep ultrasonic skin permeation employs low-frequency ultrasound to penetrate the skin’s outermost layer. This simple, fast treatment creates an imperceptible window through the skin that enables molecules to pass through with 100 times greater efficiency than intact skin, Sontra said. The SonoPrep ultrasonic skin permeation device makes the skin permeable for up to 24 hours for continuous non-invasive diagnostics.
• Spectranetics (Colorado Springs, Colorado) said that the LACI (Laser Angioplasty for Critical Limb Ischemia) clinical trial results were published in the current issue of the Journal of Endovascular Therapy. The objective of the LACI trial was to evaluate the effectiveness of excimer laser angioplasty in critical limb ischemia patients with complex blockages in their legs. The study population included only those patients who were determined to be poor or non-surgical candidates. As a result, these patients were at high risk for limb loss. The primary endpoint of the trial, limb salvage among surviving patients at six months following the initial laser treatment, was 93%.
• St. Jude Medical (St. Paul, Minnesota) reported the FDA approval and market launch of its newest platform of pacemakers, the Victory family of devices. The product will be immediately available in the U.S. and Europe. The product family received the European CE mark last fall. Among the clinically important features included in Victory pacemakers are optimized settings designed to save time at implant, Ventricular Intrinsic Preference (VIP) technology designed to minimize ventricular pacing, and the FastPath summary screen expected to speed follow-up exams. “The Victory pacemaker significantly reduced device set-up time at implant because it is pre-programmed with optimized settings that contribute to the efficiency and success of the procedure,” said Raymond Schaerf, MD, chairman of the department of surgery and chief of thoracic surgery at Providence Saint Joseph Medical Center (Burbank, California), who performed the first U.S. implant of the Victory XL DR pacemaker. The company said that physicians in Europe already are reporting the benefits of the device’s advanced technology that is designed to reduce in-clinic follow-up time without compromising patient care. Engineered to anticipate a wide variety of the diagnostic and therapy needs of patients, Victory pacemakers (models 5810 and 5816) also offer a suite of algorithms designed to make it easier for physicians to manage patients with AF. The new pacemaker family also introduces the VIP technology, an enhancement developed from clinical experience with the company’s AutoIntrinsic Conduction Search feature. VIP technology is designed to promote more natural heart function and minimize ventricular pacing.
• Sutura (Fountain Valley, California) said it has received 510(k) clearance from the FDA for use of the preloaded guidewire version of its patented SuperStitch vascular suturing device. The guidewire version of the SuperStitch allows physicians to re-access a vessel during procedures by placing the sutures first and completing suturing of the vessel after performing additional procedures if they choose. The guidewire version also enables physicians to use the SuperStitch GW on patients where they feel that maintaining access is more crucial. Sutura’s line of SuperStitch devices provide sutured closure of the arteriotomy site utilizing the existing catheter sheath introducer or cannula during fluoroscopically guided procedures and directly through the open arteriotomy during open surgical procedures.
• Tutogen Medical (Alachua, Florida), a manufacturer of sterile biological implant products made from human (allograft) and animal (xenograft) tissue, reported the introduction of an additional tissue product for use in its growing dental business. The product, Puros Pericardium Allograft Membrane, will address the needs of oral surgeons, periodontists and dentists in conjunction with bone grafting and implant procedures, by offering what the company said is an "excellent healing environment."
• Vidacare (San Antonio), manufacturer of the EZ-IO solution for immediate vascular access when conventional IV access is challenging or impossible, has received 510(k) clearance from the FDA to market its EZ-IO product system for use in pediatrics. The EZ-IO product system, which allows intraosseous access through the bone marrow cavity, provides a viable alternative to traditional intravenous access, which often is difficult to gain in pediatric patients whose veins have collapsed due to trauma or dehydration.
• VirtualScopics (Rochester, New York), a developer of image-related biomarkers, reported that it has been issued U.S. patent No. 6,984,981, “Magnetic Resonance Method and System Forming an Isotropic, High-Resolution, Three-Dimensional Diagnostic Image of a Subject from Two-Dimensional Image Data Scans.” The patent relates to a technology that improves upon the resolution and tissue contrast obtained from conventional MRI, providing more information from such images.
• Zimmer Dental (Carlsbad, California), a provider of dental oral rehabilitation products and a division of Zimmer Holdings, reported the new Hex Lock Contour Abutment. Designed to work with Tapered Screw-Vent implants, the new abutment helps to simplify the restoration process and minimize preparation time while allowing for optimum esthetics. The product is a stock titanium abutment with a prepared margin for the Tapered Screw-Vent prosthetic line that mimics the profile of soft tissue. The abutment collar is contoured below the margin to create space for soft tissue without compromising strength or esthetics, and is well-suited for cement-retained restorations, the company said. It engages the internal hex of the implant forming a friction-fit connection with the Tapered Screw-Vent implant, virtually eliminating micromovement between implant and abutment. In addition to offering a variety of cuff heights and emergence profiles, the Hex Lock Contour Abutment also offers the ability to be used in both one- and two-stage surgical protocols and can be removed for modification at a later date if changes to the prosthesis are desired.